EU Novel Food Application Updates in Q4 2025

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.

Number

Substance

Conclusions

Type of application

Publication date

Applicant

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

The Food Business Division of CIRS Group, established in 2012, has successfully assisted over 1,000 domestic and international food and feed companies in achieving "one-stop" regulatory compliance. Leveraging our extensive expertise and resources across multiple jurisdictions, we provide comprehensive compliance solutions including:

China - “Three New” Food Registration: new food material, new food additives, and new food contact materials (including synthetic biology-derived products)
China - New Feed and New Feed Additive Application
US - FDA GRAS Notice
US - Animal Food GRAS Conclusions
EU - Novel Food Application
EU - Food Enzyme (Food Enzyme Preparation) Application
EU - Food Additive Application
EU - Feed Additive Application

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