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 |
About CIRS
The Food Business Division of CIRS Group, established in 2012, has successfully assisted over 1,000 food and feed companies globally 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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