EU Novel Food Authorisation Process
How do I apply for novel food authorisation in the EU?
You apply by sending a dossier to the European Commission (not EFSA) through its online E-Submission Food Chain (ESFC) platform, under Article 10 of Regulation (EU) 2015/2283. The Commission usually passes the dossier to EFSA for a safety opinion. It then authorises the food by an implementing act that adds it to the Union list. Only foods on that list, used under its conditions and labelling rules, may be sold in the EU [1].
Approach: I worked from the in-force consolidated text of Regulation (EU) 2015/2283, the General Food Law (Regulation (EC) No 178/2002) and EFSA's guidance in the EFSA Journal. I took the submission channel from the Commission's novel food pages.
Step by step
1. Confirm the food is novel.
- A novel food is one not used for human consumption to a significant degree in the EU before 15 May 1997, and which falls into at least one of ten categories. Examples include a new or modified molecular structure; foods from microorganisms, fungi, algae or minerals; cell or tissue culture; new production processes; and engineered nanomaterials [2].
- Checking status is your job as the food business operator. If you're unsure, you must consult the Member State where you first plan to sell the food, and give it the information it needs to decide [3].
2. Choose your route.
- Full application (Articles 10-12): the standard route.
- Traditional food from a third country (Article 14): you can file a lighter notification instead. This needs documented data showing a history of safe food use outside the EU [4].
- That history means at least 25 years of continued use in the customary diet of a significant number of people in at least one third country [2].
- The route is not open to foods in categories (i), (iii), (vii), (viii), (ix) or (x) of the novel food definition.
3. Before you build the dossier (General Food Law transparency rules).
- Pre-submission advice: you can ask EFSA staff for advice on the rules and the content required. The advice does not commit EFSA's panels [5].
- Notify your studies: you must notify EFSA, without delay, of every study you commission or carry out to support the application. This covers the title, scope, laboratory and start and planned completion dates [6].
- A dossier relying on studies you didn't notify is not valid, unless you give a valid justification.
- If you then notify and resubmit, the validity check only starts six months later.
- Leaving out a study you did notify has the same consequence.
4. Prepare the dossier. Article 10(2) requires [7]:
- the applicant's name and address;
- the name and description of the novel food;
- the production process;
- the detailed composition;
- scientific evidence that the food poses no safety risk;
- analysis methods, where appropriate;
- proposed conditions of use and labelling, or a justification why these aren't needed.
EFSA's 2024 scientific guidance applies from 1 February 2025 [8]:
- Always required: identity, production process, composition, specifications, and proposed uses with use levels and anticipated intake.
- Required unless you justify why new data aren't needed: history of use, ADME, toxicology, nutrition and allergenicity.
- Animal studies: must follow GLP (Directive 2004/10/EC) [9].
For the procedural side, EFSA points you to its separate Administrative guidance for novel food applications [8]. The same applicability date covers the parallel guidance for traditional foods [10].
5. Submit on the ESFC platform.
- The platform is at webgate.ec.europa.eu/esfc and you log in with EU Login. It has been used for novel food applications and traditional food notifications since 26 March 2021 (Commission e-submission page).
- Make any confidentiality requests, with a verifiable justification, at the moment you submit [11].
- If you want five years of data protection for newly developed proprietary data, request it in the application. Article 26 sets the conditions [12].
6. Assessment and decision (statutory timelines).
- Commission to EFSA: the Commission sends the valid application to EFSA within one month of checking its validity [13].
- EFSA opinion: due within 9 months. This is extended if EFSA asks you for more information (the clock is extended by the period EFSA sets for your reply).
- Draft implementing act: within 7 months of the opinion being published, the Commission puts a draft authorising act to the Standing Committee on Plants, Animals, Food and Feed [14][15].
- Commission discretion: it may end the procedure at any stage if it considers the update unjustified. You may withdraw at any time [7].
- Traditional food notification:
- Member States and EFSA have 4 months to raise reasoned safety objections. If none are raised, the food is listed without delay [16].
- If objections are raised, you can file a full application (Article 16) [17]. EFSA then has 6 months to give its opinion [18]. The Commission then has 3 months to put a draft act to the committee [19].
Planning point: if you are also applying for a health claim on the same food with data protection, you can ask for the novel food procedure to be paused until EFSA's claim opinion arrives (Article 28) [20].
If you tell me what the food is, I can check whether it is already on the Union list and find any EFSA opinions on similar foods.
Sources: Commission: e-submission under the Novel Foods Regulation; Commission: Novel food authorisations
How long does EFSA take to assess it?
EFSA has 9 months to adopt its opinion on a full novel food application. The clock starts when EFSA receives a valid application, which the Commission must forward within one month of confirming it is valid (Article 11(1), Regulation (EU) 2015/2283) [13]. The 9 months can be extended when EFSA asks you for more data. As a result, the time from a valid application to an adopted opinion is often longer: in two recent opinions it was about 11 months in one case and about 29 months in the other.
Approach: I read the in-force consolidated text of Regulation (EU) 2015/2283 and searched EFSA Journal novel food opinions for their validity and adoption dates. The two examples are single cases I found, not EFSA statistics on average assessment times.
The statutory clock
| Route | EFSA deadline | Runs from |
|---|---|---|
| Full application (Art. 10-11) | 9 months | Receipt of a valid application [13] |
| Traditional food after safety objections (Art. 16-17) | 6 months | Receipt of a valid application [18] |
The months the Commission spends checking validity come before EFSA's clock starts. The 9 months also do not include the Commission's later step: it has 7 months after the opinion is published to put a draft authorising act to the Standing Committee.
How extensions work (Article 11(4)-(6))
The same rules apply to the 6-month traditional food clock under Article 17(4)-(6) [18].
- EFSA asks you for data: in duly justified cases, EFSA consults you and sets a deadline for your reply. It tells the Commission. Unless the Commission objects within eight working days, the 9 months are automatically extended by that period [13].
- You miss the deadline: EFSA writes its opinion on the information it already has.
- You send data without being asked: the clock is not extended, and EFSA must still deliver within the original 9 months.
Two recent examples (valid application to adopted opinion)
- Change of specifications of phytosterols/phytostanols: the application became available to EFSA as valid on 4 January 2024. The NDA Panel adopted its opinion on 28 November 2024, about 11 months later [21].
- Acheta domesticus (house cricket) powder: the application became available as valid on 26 January 2022. The opinion was adopted on 26 June 2024, about 29 months later [22].
The extracts I read don't say how long the clock was stopped in either case. Most of the difference is likely to come from data requests and the time taken to answer them, rather than EFSA's 9 months.
What shortens or lengthens it in practice
- A complete dossier helps. EFSA's 2024 guidance (applicable from 1 February 2025) lists the data you must always provide and the data you must provide or justify leaving out [8]. Gaps lead to requests for more data, and each request extends the clock.
- Answering requests quickly keeps extensions short. Data you send on your own initiative doesn't buy extra time.
- Delays before the clock starts also count: an invalid application, or studies you didn't notify to EFSA under the General Food Law (covered in my previous answer), push back the start of EFSA's 9 months.
What about the UK, how does the FSA process work?
In Great Britain (England, Scotland and Wales) you submit a novel food dossier to the Food Standards Agency (FSA) through its online regulated products application portal. The legal basis is the assimilated (retained) version of Regulation (EU) 2015/2283, and the two routes match the EU's: a full application (Article 10) or a traditional food notification (Article 14). The big difference from the EU is the decision. The FSA and Food Standards Scotland (FSS) assess the dossier, run a public consultation, and then Ministers in each nation decide. If you're approved, your food is added to the FSA's public register; since 1 April 2025 that replaces the old practice of authorising by statutory instrument. Northern Ireland still follows the EU process.
Approach: The datasets I can search don't hold the GB novel food rules or the FSA's process guidance; they only have the FSA's list of CBD products linked to novel food applications. So this answer comes from FSA guidance I opened on GOV.UK. I couldn't open the GB text of Regulation 2015/2283 on legislation.gov.uk, so I can't confirm any statutory deadline for the full application route.
Legal basis and scope
- Main law: assimilated Regulation (EU) 2015/2283 (FSA novel foods authorisation guidance).
- Supporting rules: these are assimilated versions of the EU implementing acts:
- Regulation 2018/456 sets what an Article 4 status request must contain.
- Regulation 2017/2469 covers dossiers for full applications.
- Regulation 2017/2468 covers traditional food notifications.
- Northern Ireland: to sell there, you use the European Commission's process. However, prepacked retail products authorised in GB may also go to NI if they qualify for, and move through, the Northern Ireland Retail Movement Scheme (FSA regulated products application guidance).
Step by step (FSA flowchart guidance)
Source: FSA novel foods process flowchart.
- Confirm the food is novel. Checking this is your responsibility as the food business. If you're unsure, you can ask the FSA for a status decision under Article 4 through the same portal, with supporting evidence. The FSA lists these decisions once made.
- Identify which of the ten novel food categories your product falls into. This decides what evidence you need.
- Build the dossier using EFSA's guidance. The FSA tells you to follow EFSA's novel food guidance for the parts on building the dossier. A full application has three parts:
- Part 1: administrative information;
- Part 2: identity, production process, composition, safety and toxicology, allergenicity, and nutrition;
- Part 3: glossary, laboratory certificates, full study reports and other regulators' opinions.
- Submit on the portal. You get an email with a case reference number and a secure link to follow your case. Say which information you want kept confidential when you submit (application guidance). There is no application fee (novel foods guidance).
- Validation. The FSA or FSS checks the dossier is complete. Incomplete applications are not accepted. Once validated, your application goes on the public register.
- Safety assessment. The FSA, FSS and independent experts assess the dossier. They may send you requests for further information. The results are published.
- Draft recommendation and public consultation. The FSA and FSS each draft a recommendation to authorise, authorise with conditions, or reject. The draft goes to public consultation.
- Ministerial decision. After the consultation, the final recommendations go to Ministers in each nation, who approve or refuse. You're told by email, and approved foods are added to the list of authorised products.
Traditional food route (Article 14)
- Who it's for: foods with at least 25 continuous years of consumption outside the UK or EU.
- Review period: the FSA has four months to review the notification. If no safety objections are raised, the food is authorised and added to the list.
- If objections are raised: you can apply again under Article 16 with more safety data (novel foods guidance).
How long it takes
- No published timeline: the FSA gives no timeline for full applications. It says timing depends on how complex the application is and what type of product it is, that some product types have deadlines set in law, and that the quality of your dossier "will significantly affect the time needed for assessment" (application guidance).
- Statutory deadline: I couldn't read the GB text of Article 11, so I can't tell you what deadline, if any, it sets for the FSA's opinion. Don't assume the EU's 9-month EFSA deadline carries over.
The 2025 reforms
From 1 April 2025, the Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 changed two things (FSA reforms guidance):
- Authorisation by register: an authorisation now takes effect after the Ministers' decision and is published in the official online register at data.food.gov.uk/regulated-products. A separate statutory instrument is no longer needed.
- No renewals: ten-yearly renewals for feed additives, GMOs and smoke flavourings were removed. Novel foods never needed renewal, so nothing changes for them.
Main differences from the EU process
| EU | GB | |
|---|---|---|
| Receives the application | European Commission (ESFC platform) | FSA (regulated products portal) |
| Safety assessment | EFSA | FSA and FSS, with independent experts |
| Decision | Commission implementing act after a Standing Committee vote | Ministers in England, Scotland and Wales |
| Public consultation on the draft decision | Not part of the steps covered in my earlier EU answers | Yes, on the FSA/FSS draft recommendations |
| Where authorisations appear | Union list | FSA register of authorised regulated products |
An EU authorisation does not on its own let you sell in GB, and you need a separate GB application. The FSA guidance I read doesn't describe any route that recognises EU authorisations. You can reach the FSA team at regulatedproducts@food.gov.uk.
Sources: FSA: Novel foods authorisation guidance; FSA: Regulated products application guidance; FSA: Novel foods authorisation process flowchart; FSA: Reforms to the market authorisations process for regulated products