EU Novel Food Application Updates in Q1 2026

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 three substances, comprising two new NF applications and one 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 seven applications, comprising three new NF applications, three new traditional food applications, and one modification application for an authorised NF.

Table 3 – Substances for which application dossiers 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	?????? (?)???
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 nine applications, comprising seven new NF applications and two modification applications for authorised NF.

Table 4 – Substances for which application dossiers 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 one new NF application and one 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 breastfeeding 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 a 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.

No.

Substance

Conclusions

Application type

Publication date

Applicant

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 breastfeeding 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.

3’-Sialyllactose sodium salt (3’-SL)

The applicant requests a 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
U.S. – FDA GRAS Notice
U.S. – Animal Food GRAS Conclusions
EU – Novel Food Application
EU – Food Enzyme (Food Enzyme Preparation) Application
EU – Food Additive Application
EU – Feed Additive Application

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

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