EU Novel Food Report in the First Half of 2026

Based on publicly available information from the Open EFSA and regulations issued by the European Commission, CIRS conducted a statistical analysis of the EU Novel Food (NF) approval dynamics in the first half of 2026 for enterprise reference.

As of June 30, 2026, the EU has approved 6 NFs, received 19 dossiers and accepted 15, published 9 scientific opinions.

Approved substances

The European Commission (EC) approved a total of 6 NFs. Of these, 4 were new NF authorization applications, and the remaining 2 were NF applications for revised specifications or usage conditions.

Table 1 - List of Approved NFs in the first half of 2026

No.	Substance name	Issue date	Applicant	Specification
1	Defatted rapeseed powder	2026.02.20	NapiFeryn BioTech Sp. z o.o.	Maximum use levels range from 3-20g/100g across different food categories. For FSMPs, the total daily intake must not exceed 30g. For dietary supplements intended for individuals aged 10 years and above, the maximum daily intake is 10 g.
2	Pasteurised Akkermansia muciniphila	2026.02.23	the Akkermansia Company SA	FSMPs and dietary supplements are not intended for infants and young children, children under 12 years of age, pregnant women, or lactating women. The maximum daily intake is 2.1×10¹⁰ cells/day for individuals 12 years of age and above, 3.0 × 10¹⁰ cells/day for those 14 years of age and above, and 3.4 × 10¹⁰ cells/day for adults.
3	Lacto-N-tetraose (derivative strain of E.coli K-12 MG1655)	2026.02.23	Inbiose N.V.	Maximum use levels range from 0.6–20g/kg (or g/L) across different food categories. For dietary supplements intended for individuals aged 3 years and above, the maximum daily intake is 2 g. The amount used in FSMPs shall be determined according to nutritional needs.
4	Inulin-propionate ester	2026.06.09	Imperial College Hammersmith Campus	Cereal bars: 17 g/100 g Fruit smoothies: 3 g/100 mL
5	Rhamnogalacturonan-I enriched carrot extract (cRG-I)	2026.06.11	NutriLeads BV	Approved for use in cereal products, infant foods, dietary supplements (not intended for children under 3 years of age), FSMPs, and meal replacements for weight management. Specific maximum daily intake limits or maximum content levels are established for different food categories and population groups.
6	Jatropha curcas L. (edible variety) kernels	2026.06.23	Chuta Nut GmbH	Permitted for use in nut snacks, cereal products, dried fruits, and similar products at a maximum level of 5 g/100 g. When processed into seed butter or seed powder, the maximum use level is 30 g/100 g.

Received dossiers

The EFSA received 19 NFs, including 10 NF applications, 7 traditional food applications, and 2 NF amendment applications. Among these, exotic plants and plant-derived extracts from outside the EU were the most active category in terms of submissions.

It should be noted that receipt of a dossier by the EC/EFSA does not constitute formal validation. Following submission, EFSA conducts an initial completeness check to determine whether the dossier meets the applicable administrative and technical requirements. This verification process has a statutory timeline of 30 working days. Only after the dossier is confirmed to be complete and compliant with all submission requirements will the application be formally validated and proceed to the subsequent scientific risk assessment stage.

Table 2. NFs received in the first half of 2026

No.	Name of Substance	Type of application	Receipt Date
1	Gazo (Oak Manna)	Traditional Food Application	2026.01.12
2	Phyllanthus emblica, Emblica officinalis, Amalaki, Amla, Indian Goosberry		2026.01.20
3	Burdock root (Arctium lappa L.)		2026.02.12
4	Pequi - Caryocar brasiliense		2026.04.09
5	Yanang Leaves Extract, Tiliacora triandra (Colebr.) Diels belongs to the family of Menispermaceae		2026.04.30
6	Defatted flour of cacay nuts (Caryodendron orinocense)		2026.05.05
7	Yaupon holly (Ilex Vomitoria)		2026.05.28
8	Tomato fibre	NF Application	2026.01.21
9	Turmeric (Curcuma longa L.) Oleoresin Preparation		2026.02.10
10	Cell-cultured bovine fat biomass derived from the species of cow or domesticated cattle (Bos taurus)		2026.02.13
11	Calcium Magnesium Citrate		2026.04.23
12	Acetylglucosamine (GlcNAc)		2026.04.29
13	TetraSOL, Tetradesmus obliquus Mi175.B1.a extract		2026.05.05
14	Weissella cibaria CMU (KCTC 10650BP)		2026.05.05
15	CG-A1		2026.05.08
16	Isosteviol (ent-16-oxobeyran-19-oic acid; CAS 27975-19-5 )		2026.05.28
17	Vitamin D2 Oyster Mushroom Powder		2026.05.28
18	Xia Powder 435	NF Amendment Applications	2026.02.20
19	Schizochytrium sp. oil	NF Amendment Applications	2026.05.22

Validated dossiers

In the first half of 2026, EFSA accepted 15 NF applications, including 12 NF applications and 3 amendment applications.

Table 3 - List of NFs Submitted for Acceptance in the first half of 2026

No.	Name of Substance	Type of application	Acceptance	Applicant
1	Chuta®	Modification	2026.01.06	Chuta Nut GmbH
2	6'-Sialyllactose (6'-SL) sodium salt, produced via Corynebacterium glutamicum ATCC 13032		2026.01.12	Cataya Bio (Shanghai) Co.,Ltd
3	Xia Powder 435		2026.05.05	Functional Products Trading Arica S.A./BENEXIA
4	2’-Fucosyllactose (2’-FL), produced via Kluyveromyces lactis KL-FL-6	NF Application	2026.01.12	Hengrui (Qingdao) Biotechnology Co., Ltd.
5	Calcifediol (25(OH)D)		2026.01.14	Carbogen Amcis BV
6	β-Nicotinamide Mononucleotide (β-NMN)		2026.02.19	Borealis Pharma Manufacturing B.V.
7	Schizochytrium sp. (LU310) oil		2026.02.27	LinYi YouKang Biology Co., Ltd
8	Quercetine from Dimorphandra mollis Benth		2026.03.16	SC2S
9	Xylose isomerase		2026.03.16	Intoleran. Digestive Experts
10	Human-equivalent lactoferrin alpha (heqLFα)		2026.03.25	Helaina Inc.
11	Coffee fruit extract		2026.04.07	VDF FutureCeuticals, Inc.
12	2’-Fucosyllactose (2’-FL), produced via E. coli BL21		2026.04.23	珠海市朗健生物科技有限公司
13	Cannabidiol - natural		2026.04.29	Cibdol AG
14	Gamma -Aminobutyric acid		2026.05.08	Bloomage Biotechnology Corporation Limited
15	Defatted Passion Fruit Seed Extract		2026.05.08	ALIDANS Srl

Published scientific opinions

In the first half of 2026, EFSA issued scientific opinions on 9 NFs (7 NF applications and 2 NF amendment applications).

Table 4 - NFs for which the EFSA published its scientific opinions

No.	Substance	Type of application	Publication date	Applicant	Conclusions
1	6'-Sialyllactose (6'-SL) sodium salt	Modification	2026.01.30	Inbiose N.V.	Considered safe under the proposed conditions of use.
2	3'-Sialyllactose(3'-SL) sodium salt	Modification	2026.03.25	Inbiose N.V.	Considered safe under the proposed conditions of use.
3	Carbon dioxide extract from Cannabis sativa L.	NF Application	2026.03.30	Charlotte's Web, Inc.	The safety could not be established.
4	β-Nicotinamide Mononucleotide (β-NMN)		2026.05.11	EffePharm (Shanghai) Co., Ltd.	Considered safe under the proposed conditions of use.
5	DHA-rich oil from Schizochytrium limacinum A2		2026.05.11	Huve Nutraceuticals Ltd.	The safety could not be established.
6	Nonapeptide and Pentapeptide mixture		2026.05.21	Caregen Co., Ltd	Considered safe following a reduction in the proposed use level.
7	L-alpha-glycerylphosphorylcholine from soya phospholipids (lecithin)		2026.05.22	Chemi S.P.A.	Considered safe under the proposed conditions of use.
8	Cannabidiol Isolate		2026.05.27	CBD Industries LLC	The safety could not be established.
9	Zinc L-carnosine		2026.06.17	Hamari Chemicals, Ltd	The safety could not be established.

Application Status of Chinese NFs

During the first half of 2026, NF applications submitted by the Chinese companies listed in the table below were either submitted to the EU or formally validated for assessment. Chinese applicants primarily focused on HMOs and fermentation-derived ingredients, with five applications having already entered the formal validation stage.

Table 5 - Chinese NFs in the first half of 2026

No.	Substance	Type of application	Status
1	2’-Fucosyllactose (2’-FL), produced via Kluyveromyces lactis KL-FL-6	NF Application	Accepted: 2026.01.12
2	6'-Sialyllactose (6'-SL) sodium salt, produced via Corynebacterium glutamicum ATCC 13032	Modification	Accepted: 2026.01.12
3	Schizochytrium sp. (LU310) oil	NF Application	Accepted: 2026.02.27
4	2’-Fucosyllactose (2’-FL), produced via E. coli BL21	NF Application	Accepted: 2026.04.23
5	N-acetylglucosamine (GlcNAc)	NF Application	Receipt: 2026.04.29
6	Gamma-Aminobutyric acid	NF Application	Accepted: 2026.05.08

Summary by CIRS

The application trends in the first half of 2026 indicate that plants and plant-derived extracts as well as microbial fermentation-derived ingredients remained the dominant categories of Novel Food submissions to the EU, with overseas botanical ingredients and extracts continuing to attract significant interest.

Regardless of whether the application is for a new Novel Food authorization, an amendment to an existing authorization, or a traditional food notification, the dossier must be complete, scientifically robust, and fully compliant with EU regulatory requirements. A high-quality submission can help minimize requests for supplementary information, avoid procedural delays, and facilitate a more efficient assessment process.

Note: There may be omissions and errors in the data statistics process. The data in this article is for reference only. Please refer to the information officially published by the EU. If there are any inaccuracies or inappropriate statements, CIRS Group welcomes your feedback and corrections.

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