CIRS has conducted a statistical analysis on the approval trends of Novel Food (hereinafter referred to as NF) in the EU in the fourth quarter of 2025. This is according to public information from the EU information retrieval platform Open EFSA, as of December 31, 2025.
The summary is shown in the following table:
Table 1: NF approval status in the EU in Q4 2025
|
European Commission (EC) |
Approval |
3 |
|
European Food Safety Authority (EFSA) |
Received dossiers |
6 |
|
Validated dossiers |
4 |
|
|
Published scientific opinions |
2 |
Approved substances
In the fourth quarter of 2025, EC authorized a total of three substances, including two new novel food applications and one modification application for authorised NF.
Table 2: Substances approved by the EU in Q4 2025
|
Number |
Substance |
Type of Application |
Date of Authorisation |
Applicant |
|
1 |
Clostridium butyricum TO-A |
New NF |
2025.11.06 |
TOA Biopharma Co. Ltd. |
|
2 |
Yellow tomato extract |
New NF |
2025.11.07 |
Lycored Ltd |
|
3 |
Schizochytrium sp. (ATCC PTA-9695) oil |
Modification |
2025.11.07 |
DSM Nutritional Products Europe Ltd. |
Received dossiers
In the fourth quarter of 2025, EFSA received a total of nine applications, including seven NF applications, and two modification applications for authorised NF.
Table 3: Substances for which application dossiers were received by the EFSA in Q4 2025
|
Number |
Substance |
Type of application |
Received date |
Applicant |
|---|---|---|---|---|
|
1 |
Egg Yolk Protein Extract |
New NF |
2025.10.01 |
IGY Immune Tech. & Life Sciences |
|
2 |
Pyrroloquinoline quinone disodium salt (PQQ) |
Modification |
2025.10.09 |
Compendium GmbH |
|
3 |
Defatted Passion Fruit Seed Extract |
New NF |
2025.10.14 |
ALIDANS Srl |
|
4 |
(1-carbamoyl-2-phenyl-ethyl) butyramide |
New NF |
2025.11.12 |
RHEA Innovation Srl |
|
5 |
Gamma -Aminobutyric acid |
New NF |
2025.11.13 |
Bloomage Biotechnology Corporation Limited |
|
6 |
Schizochytrium sp. (LU310) oil |
New NF |
2025.11.18 |
LinYi YouKang Biology Co., Ltd |
|
7 |
Ginger oleoresin obtained by CO2 supercritical extraction |
New NF |
2025.12.10 |
Givaudan International SA |
|
8 |
Coffee fruit extract |
New NF |
2025.12.16 |
VDF FutureCeuticals, Inc. |
|
9 |
2’-Fucosyllactose (2’-FL) |
Modification |
2025.12.17 |
珠海市朗健生物科技有限公司 |
|
18 |
Egg Yolk Protein Extract |
New NF |
2025.10.01 |
IGY Immune Tech. & Life Sciences |
Validated dossiers
In the fourth quarter of 2025, EFSA validated a total of four applications, including one NF application and three modification applications for authorised NF.
Table 4: Substances for which application dossiers were validated by the EFSA in Q4 2025
|
Number |
Substance |
Type of application |
Validated date |
Applicant |
|---|---|---|---|---|
|
1 |
Egg membrane hydrolysate |
Modification |
2025.10.06 |
Eggnovo SL |
|
2 |
Chitin-glucan from Aspergillus niger |
Modification |
2025.10.10 |
KITOZYME |
|
3 |
Ubiquinol acetate |
New NF |
2025.11.13 |
Vita Actives Limited |
|
4 |
2’-Fucosyllactose (2’-FL) |
Modification |
2025.11.14 |
虹摹生物科技(上海)有限公司 |
Published scientific opinions
In the fourth quarter of 2025, EFSA published its scientific opinions on one NF application.
Table 5: Substances for which the EFSA published its scientific opinions in Q4 2025
|
Number |
Substance |
Conclusions |
Type of application |
Publication date |
Applicant |
|---|---|---|---|---|---|
|
1 |
Galacto-oligosaccharide (GOS) |
The applicant proposed to extend the use of GOS to several food categories (non-alcoholic beverages, confectionery, chewing gum, cocoa and chocolate-based products and protein products). The target population is the general population. The EFSA Panel concludes that the proposed extension of use of GOS is safe under the proposed conditions of use. |
Modification |
2025.12.16 |
FrieslandCampina Nederland B.V. |
About CIRS
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