EU Novel Food Application Updates in Q3 2025 - including AKK, NMN, and HMOs - Regulatory News - Food & Food Contact Materials

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As of September 30, 2025, according to the public information of the EU information retrieval platform Open EFSA, CIRS has conducted statistical analysis on the approval trends of Novel Food (hereinafter referred to as NF) in the EU in the third quarter of 2025. The summary is shown in the following table:

Table 1-NF approval status in the EU in Q3 2025

European Commission (EC)	Approvals	6
European Food Safety Authority (EFSA)	Dossiers received	19
	Dossiers validated	8
	Published scientific opinions	3

Approved substances

In the third quarter of 2025, EC authorized a total of six substances, including three new novel food applications and three modification applications for authorized NF.

Table 2-Substances approved by the EU in Q3 2025

Number	Substance	Type of Application	Date of Authorisation	Applicant
1	Phytosterols/phytostanols	Modification	2025.7.25	Advanced Organic Materials SA
2	Calanus finmarchicus oil	Modification	2025.7.28	Calanus A/S
3	Schizochytrium limacinum (ATCC-20889) oil	New NF	2025.07.28	BioPlus Life Sciences
4*	3-Fucosyllactose (Escherichia coli BL21 (DE3))	Modification	2025.07.29	Chr. Hansen A/S
5	Cyperus esculentus (tiger nut) oil	New NF	2025.7.30	Tigernuts traders, S.L.
6	Potassium magnesium trichloride hexahydrate	New NF	2025.7.30	BK Giulini GmbH

*Chr. Hansen A/S submitted a dossier to the EU in April 2024, requesting an extension of 3-FL usage level. The modifications are as follows:

Food category	Original usage level	Current usage level
Infant formula	0.9 g/L	1.75 g/L
Follow-on formula	0.9 g/L
Foods for special medical purposes for infants and young children	1.2 g/L
Food supplement	3.0 g/ day	4.0 g/ day

Received dossiers

In the third quarter of 2025, EFSA received a total of 19 applications, including 13 NF applications, five modification applications for authorised NF, and one application for new traditional food from a third country.

Table 3-Substances for which application dossier were received by the EFSA in Q3 2025

Number	Substance	Type of application	Received date	Applicant
1	Chitin-glucan from Aspergillus niger	Modification	2025.07.01	KITOZYME
2	2’-Fucosyllactose	Modification	2025.07.10	虹摹生物科技(上海)有限公司
3	Kluyveromyces marxianus protein biomass	New NF	2025.07.17	上海昌进生物科技有限公司
4	ácido oleanólico oleanolic acid	New NF	2025.07.17	Plantaroma, S.L.
5	Antrodia camphorata (freeze dried mycelia)	Modification	2025.07.23	Golden Biotechnology Corp.
6	Italian Oyster mushroom (Pleurotus pulmonarius) mycelium co-fermented with Chlorella vulgaris	New NF	2025.07.28	Koralo GmbH
7	Hydroxytyrosol	New NF	2025.07.31	Nova Mentis Ltd
8	NLCs with diosgenin and glycyrrhizin	New NF	2025.08.01	AC HELCOR
9	Calcifediol (25(OH)D)	New NF	2025.08.07	Carbogen Amcis BV
10	Spermidine-rich buckwheat germ powder	New NF	2025.08.07	The Ceutics Company GesmbH
11	Neoagarooligosaccharides (NAO)	New NF	2025.08.11	Dyne Bio Inc.
12	Common Sunflower Root/ Heliantuus Annuus Radix	New traditional foods	2025.08.11	Katarzyna Jaworska
13**	Nicotinamide mononucleotide (NMN)	New NF	2025.08.21	Ralfs Bušmanis
14	7-Ketolithocholic Acid (7K-LCA)	New NF	2025.08.21	ABC Farmaceutici S.p.A.
15	Zinc Orotate Dihydrate	New NF	2025.08.26	Gall Pharma GmbH
16	Chuta®	Modification	2025.09.03	Chuta Nut GmbH
17	Quercetine from Dimorphandra mollis Benth	New NF	2025.09.09	SC2S
18	6'-Sialyllactose (6'-SL) sodium salt	Modification	2025.09.19	Cataya Bio (Shanghai) Co.,Ltd
19	2’-Fucosyllactose (Kluyveromyces lactis KL-FL-6)	New NF	2025.09.23	Hengrui (Qingdao) Biotechnology Co., Ltd

On September 29, 2025, the Natural Products Association (NPA) announced that the U.S. Food and Drug Administration (FDA) has reversed course and confirmed that Beta (β) Nicotinamide Mononucleotide (NMN) is lawful for use in dietary supplements. Please see: US FDA Confirms NMN Lawful in Dietary Supplements

Validated dossiers

In the third quarter of 2025, EFSA validated a total of eight applications, including six NF applications and two modification applications for authorised NF.

Table 4-Substances for which application dossiers were validated by the EFSA in Q3 2025

Number	Substance	Type of application	Validated date	Applicant
1	2’-Fucosyllactose (2’-FL)	Modification	2025.07.07	Cataya Bio (Shanghai) Co.,Ltd
2	Synthetic kynurenic acid	New NF	2025.07.08	Solinea Sp. zo.o.
3	Root extract of Pelargonium sidoides DC.	New NF	2025.07.09	Frutarom Switzerland Ltd.
4	Hydroethanolic Extract of Sceletium tortuosum and/or Sceletium crassicaule	New NF	2025.07.10	HG&H Pharmaceuticals
5	Broad Spectrum CBD Hemp Oil (0.0% THC)	New NF	2025.07.15	Folium Biosciences Europe B.V.
6	Galacto-oligosaccharide (GOS)	Modification	2025.07.18	FrieslandCampina Nederland B.V.
7	Maslinic rich extract from solid fraction of olives	New NF	2025.08.28	Extractos y Derivados S.L
8	Italian Oyster mushroom (Pleurotus pulmonarius) mycelium co-fermented with Chlorella vulgaris	New NF	2025.09.16	Koralo GmbH

Published scientific opinions

In the third quarter of 2025, EFSA published its scientific opinions on three NF applications.

Table 5-Substances for which the EFSA published its scientific opinions in Q3 2025

Number	Substance	Conclusions	Type of application	Publication date	Applicant
1	Lacto-N-tetraose (LNT)	The applicant requests to change the production process and specifications of the currently authorized LNT for the NF (LNT produced with a GM strain of E. coli K-12 MG1655 (ATCC 700926)). The EFSA Panel concludes that the NF is safe under the proposed conditions of use.	Modification	2025.08.13	Inbiose N.V.
2	Rapeseed protein-fibre concentrate	The EFSA Panel concludes that the NF is safe under the proposed conditions of use, provided that individuals above 10 years of age do not consume foods containing the NF and food supplements containing the NF on the same day.	New NF	2025.09.15	NapiFeryn BioTech Sp. z o.o.
3	Pasteurised Akkermansia muciniphila	The applicant requests to extend the target population for food supplements and FSMPs containing the NF to adolescents from 12 years of age and to pregnant and lactating women. The EFSA Panel concludes that the NF is safe at doses up to 2.1 × 1010 cells/day for adolescents from 12 to < 14 years, and 3.0 × 1010 cells/day for adolescents from 14 years until < 18 years. The EFSA Panel also concludes that the safety of the NF in pregnant and lactating women has not been established.	Modification	2025.09.25	The Akkermansia Company

Number

Substance

Conclusions

Type of application

Publication date

Applicant

Lacto-N-tetraose (LNT)

The applicant requests to change the production process and specifications of the currently authorized LNT for the NF (LNT produced with a GM strain of E. coli K-12 MG1655 (ATCC 700926)).

The EFSA Panel concludes that the NF is safe under the proposed conditions of use.

Modification

2025.08.13

Inbiose N.V.

Rapeseed protein-fibre concentrate

The EFSA Panel concludes that the NF is safe under the proposed conditions of use, provided that individuals above 10 years of age do not consume foods containing the NF and food supplements containing the NF on the same day.

New NF

2025.09.15

NapiFeryn BioTech Sp. z o.o.

Pasteurised Akkermansia muciniphila

The applicant requests to extend the target population for food supplements and FSMPs containing the NF to adolescents from 12 years of age and to pregnant and lactating women.

The EFSA Panel concludes that the NF is safe at doses up to 2.1 × 1010 cells/day for adolescents from 12 to < 14 years, and 3.0 × 1010 cells/day for adolescents from 14 years until < 18 years.

The EFSA Panel also concludes that the safety of the NF in pregnant and lactating women has not been established.

Modification

2025.09.25

The Akkermansia Company

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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
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