As of March 31, 2026, based on publicly available information from the EU information retrieval platform (Open EFSA), CIRS has performed a statistical review of novel food (NF) application trends in the European Union (EU) for the first quarter of 2026. The results are summarised in Table 1 below.
Table 1-NF approval status in the EU in Q1 2026
|
The European Commission (EC) |
Approval |
3 |
|
European Food Safety Authority (EFSA) |
Received dossiers |
7 |
|
Validated dossiers |
9 |
|
|
Published scientific opinions |
2 |
Approved substance
In the first quarter of 2026, the EC authorised a total of 3 substances, comprising 2 new NF applications and 1 modification application for an authorised NF.
Table 2-Substances approved by the EU in Q1 2026
|
No. |
Substance |
Application type |
Date of authorisation |
Applicant |
|
1 |
Defatted rapeseed powder |
New NF |
2026.02.20 |
NapiFeryn BioTech Sp. z o.o. |
|
2 |
Pasteurised Akkermansia muciniphila |
Modification |
2026.02.23 |
the Akkermansia Company SA |
|
3 |
Lacto-N-tetraose (derivative strain of E.coli K-12 MG1655) |
New NF |
2026.02.23 |
Inbiose N.V. |
Received dossiers
In the first quarter of 2026, EFSA received a total of 7 applications, comprising 3 new NF applications, 3 new traditional food applications, and 1 modification application for an authorised NF.
Table 3-Substances for which application dossier were received by EFSA in Q1 2026
|
No. |
Substance |
Application type |
Received date |
Applicant |
|---|---|---|---|---|
|
1 |
Turmeric (Curcuma longa L.) Oleoresin Preparation |
New NF |
2026.01.10 |
Handok Healthcare Inc. |
|
2 |
Gazo (Oak Manna) |
New traditional food |
2026.01.12 |
EKSPANDER AS |
|
3 |
Phyllanthus emblica, Emblica officinalis, Amalaki, Amla, Indian Goosberry |
New traditional food |
2026.01.20 |
ADAVED |
|
4 |
Tomato fibre |
New NF |
2026.01.21 |
Lycored |
|
5 |
Burdock root (Arctium lappa L.) |
New traditional food |
2026.02.12 |
농업회사법인 (주)한우물 |
|
6 |
Cell-cultured bovine fat biomass derived from the species of cow or domesticated cattle (Bos taurus) |
New NF |
2026.02.13 |
Mosa Meat |
|
7 |
Xia Powder 435 |
Modification |
2026.02.20 |
Functional Products Trading Arica S.A./BENEXIA |
Validated dossiers
In the first quarter of 2026, EFSA validated a total of 9 applications, comprising 7 new NF applications and 2 modification applications for authorised NF.
Table 4-Substances for which application dossier were validated by the EFSA in Q1 2026
|
No. |
Substance |
Application type |
Validated date |
Applicant |
|---|---|---|---|---|
|
1 |
Chuta® |
Modification |
2026.01.06 |
Chuta Nut GmbH |
|
2 |
2’-Fucosyllactose (2’-FL), produced via Kluyveromyces lactis KL-FL-6 |
New NF |
2026.01.12 |
Hengrui (Qingdao) Biotechnology Co., Ltd. |
|
3 |
6'-Sialyllactose (6'-SL) sodium salt |
Modification |
2026.01.12 |
Cataya Bio (Shanghai) Co.,Ltd |
|
4 |
Calcifediol (25(OH)D) |
New NF |
2026.01.14 |
Carbogen Amcis BV |
|
5 |
β-Nicotinamide Mononucleotide (β-NMN) |
New NF |
2026.02.19 |
Borealis Pharma Manufacturing B.V. |
|
6 |
Schizochytrium sp. (LU310) oil |
New NF |
2026.02.27 |
LinYi YouKang Biology Co., Ltd |
|
7 |
Quercetine from Dimorphandra mollis Benth |
New NF |
2026.03.16 |
SC2S |
|
8 |
Xylose isomerase |
New NF |
2026.03.16 |
Intoleran. Digestive Experts |
|
9 |
Human-equivalent lactoferrin alpha (heqLFα) |
New NF |
2026.03.25 |
Helaina Inc. |
Multiple NMN NF applications have been submitted to EFSA. Based on Open EFSA updates, EFSA has completed its safety assessment for EffePharm (Shanghai)’s application, with the scientific opinion due for publication in April 2026. CIRS will continue to closely track the status of NMN applications and provide updates as appropriate.
CIRS has also prepared a summary of the regulatory developments for NMN in 2025 in the United States, Australia, and the EU: : Global Regulatory Progress of NMN in the US, Australia and the EU
Published scientific opinions
In the first quarter of 2026, EFSA published its scientific opinions on 1 new NF application and 1 modification for an authorised NF.
Table 5-Substances for which the EFSA published its scientific opinions in Q1 2026
|
No. |
Substance |
Conclusions |
Application type |
Publication date |
Applicant |
|---|---|---|---|---|---|
|
1 |
Carbon dioxide extract from Cannabis sativa L. |
The applicant requests to use the NF in food supplements at maximum use levels ranging from 1.12 mg/day for children above 3 years of age to 3.60 mg/day for adults, excluding pregnant and lactating women. Given that a substantial proportion (20%–30%) of the NF remains uncharacterised, the stability and toxicological tests were performed with a material using different production process from the NF under assessment, and no data were provided by the applicant to address the safety of the NF in the general population above 3 years of age, the EFSA Panel concludes that the safety of the NF under the proposed conditions of use cannot be established. |
New NF |
2026.03.30 |
Charlotte's Web, Inc. |
|
2 |
3’-Sialyllactose sodium salt (3’-SL) |
The applicant requests to change in the production process and specifications of the currently authorised 3’-SL for the NF (3’-SL produced with a GM strain of E. coli K-12 MG1655 (ATCC 700926)), while the target population, conditions of use and consequently the anticipated intake remain unchanged. The EFSA Panel concludes that the NF is safe under the proposed conditions of use. |
Modification |
2026.03.25 |
Inbiose N.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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