The EU novel food authorisation process is governed by Regulation (EU) 2015/2283. Foods that were not consumed to a significant degree in the EU before 15 May 1997 may require novel food authorisation. The novel food pathway involves verifying novel food status, selecting the appropriate route, preparing a novel food safety dossier, submitting the application through the European Commission’s system, undergoing EFSA’s food safety assessment and, where supported, proceeding to Commission and Member State decision-making and Union List entry. Qualifying traditional foods from third countries follow a separate notification route.
Getting a Novel Food Approved in the EU: The Authorisation Pathway, Step by Step
Dr. Vikram Mehta, PhD, FRSCHead of Regulatory Affairs & Nutrition Science, Food Research Lab
Regulatory compliance, dossier preparation, and scientific documentation
Quick Answer
The EU novel food authorisation process is governed by Regulation (EU) 2015/2283. Foods that were not consumed to a significant degree in the EU before 15 May 1997 may require novel food authorisation. The novel food pathway involves verifying novel food status, selecting the appropriate route, preparing a novel food safety dossier, submitting the application through the European Commission’s system, undergoing EFSA’s food safety assessment and, where supported, proceeding to Commission and Member State decision-making and Union List entry. Qualifying traditional foods from third countries follow a separate notification route.
Introduction
Early verification of novel food status is vital for food product developers before food formulation or small- and large-scale production of novel food products. The EU novel food authorisation process can influence regulatory strategy, evidence generation and market access, making early assessment important. [1] For businesses undertaking new food product development, aligning regulatory strategy with product development from the outset can help avoid reformulation, additional studies or delayed launch.
Understanding the EU Novel Food Regulation Framework
The EU centralised system became effective in January 2018. Under Regulation (EU) 2015/2283, foods not used for human consumption to a significant degree within the EU before 15 May 1997 and falling within one of the categories defined by the Regulation may require novel-food authorisation. [2]
The novel food catalogue is a useful orientation tool for initial status checks, but it is non-exhaustive; where status is unclear, consult the relevant EU competent authority. [1]
An important development from the applicant’s perspective is the updated EFSA scientific and administrative guidance for applications submitted from 1 February 2025, which includes additional requirements and checklists, particularly the Appendix A suitability checklist. EFSA’s administrative guidance was updated again on 27 November 2025; therefore, applicants should use the latest guidance rather than older dossier formats.
The Union List under Regulation (EU) 2017/2470 serves as a reference for authorised novel foods, specifications, conditions of use and labelling. 2026 updates include defatted rapeseed powder, inulin-propionate ester, egg membrane hydrolysate and Rhizomucor pusillus mycelium, which was authorised under Commission Implementing Regulation (EU) 2026/1507 on 3 July 2026. [3]
A similar ingredient on the Union List does not automatically authorise a new material. Identity, source, production process, specifications and authorised uses must correspond to the applicable entry.
Step-by-Step: The Novel Food Authorisation Pathway
Step 1 — Confirm novel status and regulatory route
Determine whether the ingredient is novel and whether an existing Union List entry covers the specific material and proposed use. If it is a novel ingredient, determine whether it fits the standard Article 10 route or the traditional food from a third country route, which requires documented safe food use for at least 25 years by a significant number of people in at least one third country. [2]
Step 2 — Plan evidence and pre-submission activities
Preparation of an EFSA novel food application should focus on the safety questions that the supporting evidence needs to address. EFSA recommends pre-submission advice. Studies falling within the EU study-notification obligations and commissioned or carried out in support of an application after 27 March 2021 generally need to be notified to EFSA through Connect.EFSA before they begin. Applicants should verify the current notification requirements and applicable exceptions before commissioning studies. This is particularly relevant for innovative products, such as cell-culture foods or precision fermentation products, where characterisation and manufacturing controls may require a tailored evidence strategy. [1] [4]
Step 3 — Build the dossier
According to the Implementing Regulation (EU) 2017/2469, the dossier must contain sufficient information for a comprehensive assessment. [5]
Table 1. Core Dossier Assessment Areas – Simplified Overview
Dossier area | Regulatory focus |
Identity & composition | What exactly is the novel food? |
Production process | How is it manufactured and controlled? |
Specifications | What defines consistency and quality? |
Proposed uses | Where and at what levels will it be used? |
Exposure | What dietary exposure is expected? |
Safety evidence | What supports safe use? |
The revised EFSA framework and suitability checklist make dossier completeness critical: gaps at submission can prevent the application from progressing to scientific assessment.
REGULATORY READINESS REVIEW
Map ingredient identity, manufacturing, specifications, proposed uses, exposure and evidence gaps before commissioning major studies.
Step 4 — Submit and complete suitability checks
The application is submitted using the E-Submission Food Chain system (ESFC). The Commission evaluates the application, and EFSA performs the suitability evaluation before the scientific assessment and provides exposure tools such as FAIM and DietEx. The EFSA scientific evaluation requires no application fee. [1]
Step 5 — EFSA scientific assessment
The scientific evaluation is carried out by EFSA and public consultation takes place on the non-confidential dossier. If all required information is available, the evaluation should be completed within nine months; the clock stops when additional information is requested and remains stopped until the applicant’s response is received. The assessment results in an EFSA scientific opinion adopted by the NDA Panel. [1] [2]
Step 6 — European Commission authorisation and Union List entry
After EFSA’s opinion, responsibility moves to the European Commission, which, together with EU Member States, decides whether to authorise the novel food and under which conditions. Within seven months of publication of EFSA’s opinion, the Commission submits a draft implementing act to the relevant committee — though this is not a guaranteed end-to-end period. Authorisations are generally generic, but applicants can seek five-year data protection for qualifying proprietary evidence, making data-protection strategy relevant to how a commercial evidence programme is structured. [2]
Figure 1. EU novel food authorisation pathway — from status assessment to Union List entry.
Source: Regulation (EU) 2015/2283; EFSA, Novel Food Procedure.
Building a Compliant Novel Food Safety Dossier
A strong novel food safety dossier connects the information on the identity, manufacture, composition, specifications, intended uses, exposure and safety into one coherent safety case.
Essential Technical Dossier Requirements
The dossier should explain why the selected studies are appropriate and how their results support the safety case under the proposed conditions of use, particularly when the formulation, source material or manufacturing controls differ from those of previously assessed materials. [1] [5]
The dossier should describe the material that will reach the EU market. Changes in source, process, composition, specification, formulation level or intended food category can affect the relevance of the supporting safety evidence.
EFSA’s Role in the Scientific Assessment
EFSA is the scientific risk assessor; it does not give market authorisation. The European Commission authorisation, with Member State participation, is the risk-management decision. [6]
Table 2. EU Novel Food Regulatory Responsibilities [1] [2]
Stage | Main responsibility | Output |
Status & dossier | Applicant | Regulatory strategy and application |
Scientific assessment | EFSA | EFSA scientific opinion |
Risk management | Commission + Member States | Authorisation decision |
Market conditions | European Commission | Union List entry |
NOVEL FOOD DOSSIER SUPPORT
Align formulation, specifications, manufacturing controls, exposure assessment and safety evidence into a submission-ready dossier.
Common Reasons Novel Food Applications Are Delayed
Common causes of avoidable delays include insufficient characterisation of the novel food, inconsistent specifications, inadequately justified exposure assumptions, insufficient study quality and evidence gaps that prevent a clear safety conclusion. These deficiencies may result in requests for additional information and extend the assessment timeline through clock stops.
For businesses assessing EU novel food approval requirements, resolving these before submission reduces avoidable time and evidence costs. [1] [2]
Figure 2. Key timing points in the EU novel food authorisation process.
Source: Regulation (EU) 2015/2283, Articles 11–12; EFSA.
For a traditional food third-country notification, a valid notification is forwarded to the Member States and EFSA, which have four months to raise duly reasoned safety objections. If no objection is raised, the Commission can proceed with authorisation and update the Union List. If a safety objection is raised, the applicant may submit an Article 16 application for EFSA assessment. [2] [7]
Conclusion
An effective EU novel food authorisation process involves early classification, appropriate guidance, evidence planning, dossier development and a clear understanding of the responsibilities of EFSA and the Commission. For businesses pursuing new food product development, regulatory planning should advance alongside food formulation, testing and manufacturing — not after them.
Food Research Lab: End-to-End Novel Food Support
Food Research Lab supports businesses with food product development services, novel food status assessment and regulatory strategy through formulation, evidence planning, technical dossier preparation and regulatory support.
Frequently Asked Questions
A novel food generally falls under Regulation (EU) 2015/2283 where it was not consumed to a significant degree in the EU before 15 May 1997 and meets one of the defined categories. The list of novel food catalogue is used as the basis for a pre-assessment but is not comprehensive.
There is no guaranteed end-to-end timeline. EFSA’s scientific assessment should take nine months when all necessary information is available, but additional-data requests stop the clock, and the Commission’s subsequent procedure has its own steps.
A novel food safety dossier should include information on identity, production, composition, specifications, intended uses, exposure and appropriate nutritional, toxicological and allergenicity evidence in accordance with current EFSA guidance.
A traditional food third country notification is an alternative route for a traditional food with at least 25 years of documented safe use in a third country. Following a valid notification, Member States and EFSA have four months to raise duly reasoned safety objections. If no objection is raised, the Commission can proceed with authorisation and update the Union List. If a safety objection is raised, the applicant may submit an Article 16 application for EFSA assessment.
References
- European Food Safety Authority. (n.d.). Novel food applications. EFSA – Novel food applications
- European Parliament & Council of the European Union. (2015). Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods. Official Journal of the European Union. EUR-Lex – Regulation (EU) 2015/2283
- European Commission. (n.d.). Union list of novel foods. European Commission – Union list of novel foods
- European Parliament & Council of the European Union. (2019). Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain. Official Journal of the European Union. EUR-Lex – Regulation (EU) 2019/1381
- European Commission. (2017). Commission Implementing Regulation (EU) 2017/2469 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 on novel foods. Official Journal of the European Union. EUR-Lex – Implementing Regulation (EU) 2017/2469
- European Food Safety Authority. (n.d.). Novel food. EFSA – Novel food topic
- European Food Safety Authority. (n.d.). Traditional foods. EFSA – Traditional foods
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