Overview of U.S. FDA GRAS Notices in 2025

In 2025, U.S. GRAS notices remained highly active. To provide a comprehensive overview of the annual trends, CIRS Group conducted a systematic review and analysis of GRAS notices in 2025, offering insights and references for enterprises.

It should be noted that updates on the FDA website may be delayed, and many substances may have actually completed GRAS notices, but their status has not yet been updated. CIRS will closely monitor the FDA updates, and this discussion is based on the final information available on the FDA website for 2025.

Summary of FDA GRAS notices in 2025

The statistical results show that in 2025, a total of 91 substances had their information updated. Specifically, 30 substances were newly submitted during the year, 56 substances were newly filed, and 65 substances received new responses within the year.

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Figure 1. GRAS notice in 2025

In 2025, a total of 56 substances received “FDA has no questions” letters, seven ceased to be evaluated, and two notices did not provide a basis for a GRAS determination. Additionally, 26 substances are still pending.

Figure 2. Overview of GRAS notices in 2025

Substances notified in 2025: a total of 56 substances

A total of 56 substances were notified in 2025, including 30 microorganism-related substances, three sugar substitute ingredients, three HMOs, and 20 substances in other categories.

The applicants originated from multiple countries, including the United States, China, Ireland, Germany, Denmark, Japan, France, the Netherlands, and India. Among them, U.S. and Chinese companies were the two main contributors of substances that obtained GRAS notices, with 25 substances and 19 substances, respectively.

Table 1. FDA GRAS substances notified in 2025

No.	GRN No.	Substance	Notified date	Enterprise
1	1182	Hydroxytyrosol	Feb 12, 2025	Hangzhou Viablife Biotech Co, Ltd. (China)
2	1187	Polygalacturonase enzyme preparation produced by Trichoderma reesei expressing a gene encoding polygalacturonase from Aspergillus luchuensis mut kawachii	Feb 28, 2025	AB Enzymes Inc. (US)
3	1192	Tannase enzyme preparation produced by Aspergillus oryzae	Mar 14, 2025	Mitsubishi Chemical Corporation (Japan)
4	1195	Chymosin enzyme preparation produced by Aspergillus niger expressing a gene encoding chymosin from Erinaceus europaeus	Mar 6, 2025	Chr. Hansen A/S (Denmark)
5	1196	Triacylglycerol lipase enzyme preparation produced by Trichoderma reesei expressing a gene encoding an engineered triacylglycerol lipase from Thermomyces lanuginosus	Mar 3, 2025	AB Enzymes Inc. (US)
6	1197	Fructanase enzyme preparation produced by Trichoderma reesei AR-577 expressing the gene encoding fructanase from Lactobacillus crispatus	Mar 14, 2025	AB Enzymes Inc. (US)
7	1198	Inositol	Feb 3, 2025	Sichuan Bohaoda Biological Technology Co., Ltd. (China)
8	1199	Rhamnogalacturonan-I	Feb 28, 2025	G3P Inc. (US)
9	1200	β-lactoglobulin produced by Komagataella phaffii strain VIPLA	Feb 28, 2025	Vivici B.V. (the Netherlands)
10	1201	Lipase enzyme preparation produced by Komagataella phaffii expressing a gene encoding lipase from Yarrowia lipolytica	Mar 10, 2025	Chr. Hansen A/S (Denmark)
11	1202	Soy leghemoglobin preparation from a strain of Komagataella phaffii	Mar 7, 2025	Impossible Foods Inc (US)
12	1203	Rebaudioside M2 obtained by enzymatic treatment of steviol glycosides purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni	Feb 12, 2025	Guilin Layn Natural Ingredients Corp. (China)
13	1204	Lacticaseibacillus casei Zhang	Feb 19, 2025	Beijing Scitop Bio-tech Co., LTD (China)
14	1205	Lactiplantibacillus plantarum DR7	Mar 24, 2025	Kaneka Americas Holding, Inc. (US)
15	1206	Rebaudioside M produced by enzymatic treatment of rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni	Feb 28, 2025	Adorvia Biotechnology Co., Ltd. (China)
16	1207	Brazzein preparation produced by Aspergillus oryzae 90402 expressing a gene encoding for brazzein from Pentadiplandra brazzeana	Apr 10, 2025	Nanjing Bestzyme Bio-Engineering Co. Ltd. (China)
17	1208	Lacto-N-triose II	Apr 29, 2025	Shandong Henglu Biotechnology Co., Ltd. (China)
18	1210	Glucosyltransferase enzyme preparation produced by Bacillus subtilis expressing the gene encoding glucosyltransferase from Streptococcus salivarius	Aug 15, 2025	Danisco US Inc. (US)
19	1211	Reduced minerals goat whey	Feb 4, 2025	Crossway Foods Limited (Ireland)
20	1212	Liquid whole goat milk	Feb 7, 2025	Crossway Foods Limited (Ireland)
21	1213	Goat milk lactose	Feb 21, 2025	Crossway Foods Limited (Ireland)
22	1214	Bacillus clausii UBBC-07 spore preparation	May 7, 2025	Unique Biotech Limited (India)
23	1215	Bacteriophage (phage) preparation specific to Listeria monocytogenes	Jun 6, 2025	FINK Tec GmbH (Germany)
24	1218	Bacillus subtilis NRRL 68054	Apr 29, 2025	Microbial Discovery Group LLC (US)
25	1219	Recombinant bovine lactoferrin isolate produced by Komagataella phaffii M020 expressing the gene encoding bovine lactoferrin	May 7, 2025	TurtleTree Inc (US)
26	1221	Heyndrickxia coagulans NRRL B-67744	Jun 9, 2025	Microbial Discovery Group, LLC (US)
27	1222	Saccharomyces cerevisiae OYR-542	May 5, 2025	Suntory Global Spirits (US)
28	1223	Sakura (Prunus serrulata Lindl.) flower distillate	Jun 3, 2025	Suntory Global Spirits (US)
29	1224	Sakura (Prunus serrulata Lindl.) flower extract	Jun 3, 2025	Suntory Global Spirits (US)
30	1225	Sakura (Prunus speciosa) leaf distillate	Jun 3, 2025	Suntory Global Spirits (US)
31	1226	Orange (Citrus sinensis) extract	Jun 9, 2025	BioActor B.V./Solabia Nutrition (Netherlands)
32	1229	Levilactobacillus brevis ATCC SD-7285	Aug 15, 2025	International Flavors & Fragrances, Inc. / Danisco USA, Inc.
33	1230	Vanillin preparation produced by Escherichia coli BL21(DE3) SI-VAN1	Jun 11, 2025	Sichuan Ingia Biosynthetic Co., Ltd. (China)
34	1231	Bacillus velezensis PTA-127359	Jul 11, 2025	BIO-CAT Microbials, LLC
35	1232	Lacticaseibacillus paracasei DSMZ 28047	Aug 6, 2025	SunWay Biotech Co., Ltd.(Taiwan)
36	1233	Sansho (Zanthoxylum piperitum) pepper distillate	Jul 8, 2025	Suntory Global Spirits (US)
37	1234	Sansho (Zanthoxylum piperitum) pepper extract	Jul 14, 2025	Suntory Global Spirits (US)
38	1235	Bifidobacterium lactis CCTCC M 2014588	Sep 2, 2025	Bioflag Co., Ltd (China)
39	1236	Algal oil (≥40% docosahexaenoic acid) from Aurantiochytrium limacinum H Sc-01	Jun 10, 2025	Shaanxi Healthful Bioengineering Co., Ltd. (China)
40	1238	2'-fucosyllactose	Jun 17, 2025	Cataya Bio (Shanghai) Co., Ltd. (China)
41	1239	Bifidobacterium animalis subsp. lactis PTA-126817	Jun 11, 2025	Wecare Probiotics Co., Ltd. (China)
42	1240	Lacticaseibacillus rhamnosus ATCC PTA-126815	Jul 8, 2025	Wecare Probiotics Co., Ltd. (China)
43	1241	β-lactoglobulin produced by Aspergillus oryzae	Sep 16, 2025	Bon Vivant SAS (France)
44	1242	Short-chain fructooligosaccharides	Jul 14, 2025	BENEO GmbH (Germany)
45	1243	Bacillus coagulans M2017813 spore preparation	Aug 21, 2025	Thankcome Biological Science and Technology Co., Ltd. (China)
46	1244	Lactiplantibacillus plantarum DSM 21380	Aug 5, 2025	NORDWISE BioTech OÜ (US)
47	1245	Lactiplantibacillus plantarum DSM 21379	Aug 5, 2025	NORDWISE BioTech OÜ (US)
48	1246	Saccharomyces cerevisiae BY-1248	Sep 22, 2025	Berkeley Fermentation Science Inc. (US)
49	1247	β-Lactoglobulin produced by Kluyveromyces lactis CCTCC M20241460	Sep 19, 2025	Shanghai Changing Biotechnology Co., Ltd. (China)
50	1248	Yeast biomass produced by Kluyveromyces marxianus CCTCC M 20211265	Sep 23, 2025	Shanghai Changing Biotechnology Co., Ltd. (China)
51	1249	Ovalbumin produced by Trichoderma reesei ATCC 13631	Sep 16, 2025	Onego Bio, Inc. (US)
52	1251	Saccharomyces cerevisiae expressing a gene encoding a cysteine-thiol lyase from Staphylococcus hominis (S. cerevisiae "OYR-290")	Sep 23, 2025	Omega Yeast Labs, LLC (US)
53	1252	Saccharomyces cerevisiae "BY-1568"	Sep 23, 2025	Berkeley Fermentation Science Inc. (US)
54	1264	Lacticaseibacillus rhamnosus CGMCC18639	Dec 9, 2025	Beijing Scitop Bio-Tech Co., Ltd. (China)
55	1265	Saccharomyces cerevisiae "BY-1532"	Dec 11, 2025	Berkeley Fermentation Science Inc. (US)
56	1274	2'-fucosyllactose	Dec 8, 2025	Tianjin Hesheng Biotechnology Co., Ltd. (China)

Substances notified by Chinese companies in 2025: a total of 19 substances

In 2025, a total of 19 substances from Chinese companies received “FDA has no questions” letters, including eight microorganism-related substances, three sugar substitutes/sweeteners, three HMOs, and four substances in other categories.

Table 2. Substances notified by Chinese companies receiving “FDA has no questions” letters in 2025

No	GRN No.	Substance	Notified Date	Enterprise
1	1264	Lacticaseibacillus rhamnosus CGMCC18639	Dec 9, 2025	Beijing Scitop Bio-Tech Co., Ltd. (China)
2	1274	2'-fucosyllactose	Dec 8, 2025	Tianjin Hesheng Biotechnology Co., Ltd. (China)
3	1182	Hydroxytyrosol	Feb 12, 2025	Hangzhou Viablife Biotech Co, Ltd. (China)
4	1198	Inositol	Feb 3, 2025	Sichuan Bohaoda Biological Technology Co., Ltd. (China)
5	1203	Rebaudioside M2 obtained by enzymatic treatment of steviol glycosides purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni	Feb 12, 2025	Guilin Layn Natural Ingredients Corp. (China)
6	1204	Lacticaseibacillus casei Zhang	Feb 19, 2025	Beijing Scitop Bio-tech Co., LTD (China)
7	1206	Rebaudioside M produced by enzymatic treatment of rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni	Feb 28, 2025	Adorvia Biotechnology Co., Ltd. (China)
8	1207	Brazzein preparation produced by Aspergillus oryzae 90402 expressing a gene encoding for brazzein from Pentadiplandra brazzeana	Apr 10, 2025	Nanjing Bestzyme Bio-Engineering Co. Ltd. (China)
9	1208	Lacto-N-triose II	Apr 29, 2025	Shandong Henglu Biotechnology Co., Ltd. (China)
10	1230	Vanillin preparation produced by Escherichia coli BL21(DE3) SI-VAN1	Jun 11, 2025	Sichuan Ingia Biosynthetic Co., Ltd. (China)
11	1232	Lacticaseibacillus paracasei DSMZ 28047	Aug 6, 2025	SunWay Biotech Co., Ltd. (Taiwan)
12	1235	Bifidobacterium lactis CCTCC M 2014588	Sep 2, 2025	Bioflag Co., Ltd (China)
13	1236	Algal oil (≥40% docosahexaenoic acid) from Aurantiochytrium limacinum H Sc-01	Jun 10, 2025	Shaanxi Healthful Bioengineering Co., Ltd. (China)
14	1238	2'-fucosyllactose	Jun 17, 2025	Cataya Bio (Shanghai) Co., Ltd. (China)
15	1239	Bifidobacterium animalis subsp. lactis PTA-126817	Jun 11, 2025	Wecare Probiotics Co., Ltd. (China)
16	1240	Lacticaseibacillus rhamnosus ATCC PTA-126815	Jul 8, 2025	Wecare Probiotics Co., Ltd. (China)
17	1243	Bacillus coagulans M2017813 spore preparation	Aug 21, 2025	Thankcome Biological Science and Technology Co., Ltd. (China)
18	1247	β-Lactoglobulin produced by Kluyveromyces lactis CCTCC M20241460	Sep 19, 2025	Shanghai Changing Biotechnology Co., Ltd. (China)
19	1248	Yeast biomass produced by Kluyveromyces marxianus CCTCC M 20211265	Sep 23, 2025	Shanghai Changing Biotechnology Co., Ltd. (China)

Substances notified by Chinese companies in pending status in 2025

According to the latest information available on the FDA website, in 2025, Chinese companies had a total of 12 newly pending substances. HMOs were the primary category of submissions, with five substances pending, including 2′-fucosyllactose, lacto-N-neotetraose, lacto-N-tetraose, and 6′-sialyllactose sodium salt. There were four microorganism-related substances pending, including three microbial strains and one mycelial biomass. The remaining three substances were lycopene preparations, fungal oil, and L-ergothioneine.

Note: Due to potential delays in updates on the FDA website, it cannot be ruled out that some of these substances have already completed the review process but have not yet been publicly disclosed.

Table 3. Substances in pending status notified by Chinese enterprises in 2025

No.		Substance	Enterprise
1	1253	Lycopene preparation produced by Saccharomyces cerevisiae JZL03	Wuhan Hesheng Technology Co., Ltd.
2	1255	Mycelial biomass of Fusarium compactum CGMCC 41312 (fungal protein)	MoreMeat (Guangzhou) Biotech Co., Ltd
3	1259	Fungal oil (≥40% arachidonic acid (ARA)) from Mortierella alpina strain TKA-1	ATK Biotech Co., Ltd.
4	1261	2'-fucosyllactose	Suzhou Yixi Biotech Co., Ltd.
5	1262	2'-fucosyllactose	Zhuhai Long Health Biotechnology Co., Ltd.
6	1270	L-ergothioneine produced by Escherichia coli K-12 MG1655 expressing enzymes from Neurospora crassa and Mycolicibacterium smegmatis MC2 155	Gene III Biotechnology Co., Ltd.
7	1272	Lacto-N-neotetraose	Shenzhen Long Health Biotechnology Co., Ltd.
8	1273	Lacto-N-tetraose	Shenzhen Long Health Biotechnology Co., Ltd.
9	1275	6′-sialyllactose sodium salt	Cataya Bio (Shanghai) Co., Ltd.
10	1277	Autoclaved Parabacteroides goldsteinii “RV-01”	ReviveBio, Co.
11	1278	Lactiplantibacillus plantarum CGMCC 6312	Beijing Scitop Bio-Tech Co., Ltd.
12	1279	Saccharomyces cerevisiae CCTCC M2025194	Angel Yeast Co., Ltd.

Summary

The GRAS notice trends in 2025 show that microorganism-related substances – with 30 newly approved substances – were the undisputed mainstay of submissions, covering a wide range of probiotics, enzyme preparations, and emerging mycelial biomass products. Sugar substitutes and HMOs also maintained strong momentum in submissions, reflecting the market’s continued focus on sugar reduction and precision nutrition.

A key highlight of the year was the strong performance of Chinese biotechnology companies. Based on the latest information available from the FDA, 19 substances received “FDA has no questions” letters, while 12 additional substances remained pending, demonstrating the innovation capacity and growing competitiveness of Chinese companies in the global ingredients market.

*Data Source: The inventory of GRAS notices and the latest released accepted GRAS dossiers (updated as of 2025/12/30).

*Note:

1. As the FDA doesn’t disclose dossier acceptance dates, the statistics for substances in pending status are primarily based on the submission dates recorded in the released dossiers.

2. The statistics are based on the published dossiers with GRN No., and are for reference only.

About CIRS

The Food Division of CIRS Group was established in 2012 and it has a professional team specializing in US GRAS notices. The CIRS Food Division has extensive experience in various fields, covering GRAS, new food ingredients, new food additives, food contact materials, synthetic biology foods, EU Novel Foods, dietary supplements, and special dietary foods.

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