2025 EU Novel Food Annual Report

Based on publicly available information from the Open EFSA and regulations issued by the European Commission, CIRS conducted a statistical analysis of the EU Novel Food (NF) approval status in 2025 for enterprise reference.

As of December 31, 2025, the EU NF approval dynamics are shown in Figure 1:

Figure 1. Approval status of EU NFs in 2025

Approved substance

The European Commission (EC) approved a total of 17 NFs, with a relatively even distribution across the four quarters. Of these, 10 were new NF authorization applications (including one traditional food from a third country originating in Brazil), and the remaining 7 were NF applications for revised specifications or usage conditions. A summary list is shown in Table 1. Microbial strains and plant extracts remain popular choices for NF applications.

Table 1 - List of NF Substances Approved by the EU in 2025

Received dossiers

The EFSA received 47 NFs, including 32 NF applications, 5 traditional food applications, and 10 NF amendment applications.

Of these 47 NFs, 5 are human milk oligosaccharides (HMOs), 1 is human equivalent lactoferrin α, 8 are microbial, fungal, or algal extracts, 12 are plants or their extracts, 2 are animals or their extracts, 17 are chemical substances, and 2 are nicotinamide mononucleotides (NMN). NMN has been a highly anticipated substance. For more details, please read the article “Global Regulatory Progress of NMN in the US, Australia and EU” compiled by CIRS Group.

Table 2. NFs submitted and validated by EFSA in 2025

Validated dossiers

In 2025, EFSA accepted 29 NF applications, including 21 NF applications and 8 amendment applications. The list includes 2 HMOs, both 2'-FL, 10 microorganisms, fungi, or algae or their extracts, 5 plants or their extracts, 2 animals or their extracts, and 10 chemical substances.

EFSA’s receipt of an application dossier does not guarantee immediate acceptance. A preliminary review is required, typically within 30 working days (excluding time for supplementary information) to confirm the dossier’s completeness and compliance with application requirements before proceeding to the acceptance stage. CIRS Group has compiled a list of NFs submitted and accepted in 2025. The fastest acceptance was for Koralo GmbH’s new NF “Italian Oyster mushroom (Pleurotus pulmonarius) mycelium co-fermented with Chlorella vulgaris”, which took 51 calendar days. Therefore, when submitting a substance application dossier to the EU, it is crucial to ensure the dossier is scientifically sound, complete, and meets the informational requirements to expedite the next stage and accelerate the application process.

Table 3 - List of NFs Submitted to EU for Acceptance in 2025

Published scientific opinions

In 2025, EFSA issued scientific opinions on 28 NFs, categorized into 2 applications for traditional foods from third countries, 18 NF applications, and 8 NF amendment applications. These include 2 HMOs, 9 microorganisms, fungi or algae or their extracts, 6 plants or their extracts, 3 animals or their extracts, and 8 chemical substances. CIRS listed the NFs of most concern in the table below. A detailed list of NFs can be found on the Open EFSA.

Table 4 - NFs for which the EFSA published its scientific opinions

Application Status of Chinese Companies

An increasing number of Chinese companies are pursuing overseas applications. In 2025, the NF applications submitted by the Chinese companies listed in the table below have been submitted to or accepted by the EU.

Table 5 - Chinese Companies Applying for New Food Substances in the EU in 2025

Summary by CIRS

From the dynamics of recent applications, microorganisms and their derivatives, as well as plants and their extracts, remain the preferred categories for NF submissions. Whether applying for a new NF or submitting a modification request, applicants must ensure that the dossier is complete, scientifically robust, and compliant with data requirements in order to move efficiently to the next stage and accelerate the overall approval process.

In 2025, the European Union maintained overall stability in the approval and management of Novel Foods. To enhance the scientific rigor and transparency of the submission process, the EU systematically revised several administrative guidance documents, including those related to Novel Foods and food improvement agents, based on accumulated regulatory experience. These revisions further clarified data requirements, assessment procedures, and compliance standards, thereby helping companies advance their applications more effectively.

At the same time, the rapid development of synthetic biology has led to a growing number of applications involving products derived from genetically modified microorganisms. In response, the EFSA issued an updated Guidance on the safety assessment of microorganisms used in the food chain to address the safety evaluation needs arising from this emerging technological field. The revised guidance provides more detailed scientific direction regarding molecular characterization, metabolic pathways, allergenicity, and potential toxicity. It not only strengthens the safety oversight framework but also offers clear and efficient technical support for companies engaged in related research, development, and regulatory submissions.

Note: There may be omissions and errors in the data statistics process. The data in this article is for reference only. Please refer to the information officially published by the EU. If there are any inaccuracies or inappropriate statements, CIRS Group welcomes your feedback and corrections.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.