NOMAD Bioscience Receives GRAS Regulatory Recognition by FEMA for Its Plant-Made Natural Thaumatin II as a Flavour Modifier/Enhancer
NOMAD Bioscience GmbH received a formal GRAS recognition letter from the Flavor and Extract Manufacturers Association (FEMA) in response to NOMAD’s GRAS application describing use of plant-expressed Thaumatin II as a flavour modifier/enhancer (FEMA GRAS 5010). FEMA’s expert panel has affirmed Thaumatin II as a GRAS substance that can be safely used in a wide variety of foods and beverages at an average maximum use level of 7 ppm.
Thaumatin II is a natural flavour modifier and non-caloric high intensity sweetener, and NOMAD’s lead product candidate with new superior attributes. GRAS is a facilitated US regulatory marketing allowance pathway for food substances and ingredients that are ‘Generally Recognized As Safe’ under conditions of intended use.
NOMAD has earlier received its first regulatory GRAS clearances from FDA for thaumatins made in alternative plant hosts as sweeteners in 2018 (GRAS 738) and for Thaumatin II as a sweetener (GRAS 910) and a taste modifier (GRAS 920) in 2020. The FEMA designation broadens our registration activity to markets in other important geographies. FEMA regulatory certificates are accepted and used as the basis for market approvals in over 100 countries (https://www.femaflavor.org/).
Thaumatin mixtures consisting mainly of Thaumatin I and Thaumatin II and extracted from its natural source plant Thaumatococcus received regulatory approvals as sweetener or flavour modifier decades ago, and they are on the market in US, EU, Japan, and many other countries. The much wider use of the product is however limited because of low and unreliable supply of natural plant species resulting in high price of the product.
About NOMAD Bioscience GmbH. NOMAD Bioscience GmbH is a plant biotechnology company developing a broad range of protein products food safety and medicine markets. Among the product candidates in development are antiviral biologics, non-antibiotic antimicrobials (bacterial bacteriocins and phage lysins), as well as natural high intensity non-caloric sweetener proteins thaumatins and brazzeins as sugar replacements and taste modifiers. Corporate offices are headquartered in Munich, Germany and the Company’s Research Division is located in Halle, Germany. NOMAD intends to commercialize its products for food markets through its spin-off company NAMBAWAN Biotech.
For additional information, visit our website https://www.nomadbioscience.com/