Summary of US FDA GRAS Acceptance and Approval Status in the First Quarter of 2024

In the first quarter of 2024, the official website of the FDA updated the GRAS status of 27 products. Among these, approval was granted for 2 substances, 2 substances ceased to be evaluated at the notifier’s request, and 23 substances are still pending after submission.

This article provides a summary of the US FDA GRAS acceptance and approval status in the first quarter of 2024, for the information and reference of businesses.

US,Food,GRAS,Approval,Acceptance

1. Approved FDA GRAS substances in the first quarter of 2024 (FDA has no questions)

No.	GRN No.	Substance	Date of approval	Applicant
1	1137	Protein-sucrose	2024.1.19	Incredo Ltd. (Israel)
2	1142	Brazzein	2024.3.11	Oobli, Inc. (US)

2. Substances ceased to be evaluated at the notifier’s request in the first quarter of 2024

No.	GRN No.	Substance	Date	Applicant
1	1156	Algal oil (≥35% docosahexaenoic acid) from Schizochytrium sp. FJRK-SCH3	2024.2.8	Runke Bioengineering (Fujian) Co., Ltd. (China)
2	1162	Fungal oil (≥ 38% arachidonic acid (ARA)) from Mortierella alpina FJRK-MA01	2024.2.8	Runke Bioengineering (Fujian) Co., Ltd. (China)

3. Pending substances in the first quarter of 2024

No.	GRN No.	Substance	Applicant
1	1138	Hydroxytyrosol	Hangzhou Viablife Biotec (China)
2	1139	Transglutaminase enzyme preparation produced by Bacillus licheniformis carrying a gene encoding transglutaminase from Streptomyces mobaraensis	Novozymes North America (US)
3	1140	Enzyme-modified steviol glycosides	Tate & Lyle (US)
4	1141	L-α-glycerophosphorylcholine	Shenyang Gold Jyouki Technology Co., Ltd (China)
5	1143	Bacillus subtilis NRRL 68053	Microbial Discovery Group (US)
6	1144	Miracle fruit (Synsepalum dulcificum) powder	Miracle Fruit Farm LLC (US)
7	1145	β-lactoglobulin produced by Aspergillus oryzae strain Ao_st0002	Imagindairy Ltd. (Israel)
8	1146	Nuclease enzyme preparation produced by Bacillus amyloliquefaciens expressing the gene encoding a nuclease from Serratia marcescens	c-LEcta GmbH (Germany)
9	1147	Copper(II) ion	Copperprotek SPA (Chile)
10	1148	D-psicose	Daesang Corporation (South Korea)
11	1149	High-selenium Saccharomyces cerevisiae yeast	Cypress Systems, Inc. (US)
12	1150	Triacylglycerol lipase enzyme preparation produced by Trichoderma reesei expressing a gene for triacylglycerol lipase from Thermomyces lanuginosis	AB Enzymes Inc. (US)
13	1151	Fava ben protein	Cooperative Koninklijke Cosun U.A. (Netherlands)
14	1152	Phoenix oyster mushroom (Pleurotus pulmonarius) mycelia biomass	Mushlabs GmbH (Germany)
15	1153	Pongamia bean oil	Terviva, Inc. (US)
16	1154	Triacylglycerol lipase enzyme preparation produced by Komagataella phaffii expressing the gene encoding lipase from Fusarium oxysporum	Lallemand Inc. (Canada)
17	1155	1-methylcyclopropene	Fresh Inset S.A. (Poland)
18	1157	2'-fucosyllactose	Synaura Biotechnology (Shanghai) Co., Ltd. (China)
19	1158	Lactiplantibacillus plantarum DSM 34613	Scott Laboratories, Inc. (US)
20	1159	Bacillus coagulans strain BCP92 spore preparation	Pellucid Lifesciences Pvt., Limited (India)
21	1160	Lemna leaf protein	Plantible Food (US)
22	1161	Triacylglycerol lipase enzyme preparation produced by Candida cylindracea	Meito Sangyo Co., Ltd (Japan)
23	1163	A preparation containing two bacteriophages (phage) specific to Salmonella enterica	Cytophage Technologies inc. (Canada)

Source: The inventory of GRAS notices, for reference only.

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