GRAS Microbial-Derived Ingredients

As a leading CDMO, BOC Sciences focuses on the use of microorganisms for fermentation to produce valuable chemical ingredients. For customers in the food, nutraceutical, and feed industries, we are confident and capable of providing microbial-derived ingredients and helping analyze whether your ingredients require GRAS status.

With a CNAS certified laboratory, and extensive experience in strain identification and fermentation production, we perform safety assessments of microbial-derived ingredients in food products. Our strong team of GRAS experts is able to act as a liaison with the FDA to prepare GRAS documentation for our clients to help food manufacturers who need to submit safety related data.

Introduction of Microbial-Derived Ingredients

Microorganisms can be used as a source for food ingredient production; bacteria, yeast and microalgae can be used as catalysts for the production of food ingredients, enzymes and nutraceuticals. Microbial-derived ingredients, such as proteins, enzymes, polysaccharides, vitamins and antibiotics, produced through microbial fermentation, have been widely used in the food industry. New food ingredients must be pre-approved by the FDA, and new food ingredients that are generally considered safe are regulated through the GRAS system. Some microbial-derived ingredients have been reviewed by the FDA and confirmed to be generally recognized as safe (GRAS) for defined purposes (e.g., indirect human food ingredients) and conditions.

Examples of GRAS microbial-derived ingredients

In addition, some GRAS microbial-derived ingredients are restricted for use on food contact surfaces. For example, dextran produced by bacterial fermentation, and sorbitol made by bacterial oxidation of sorbitol.

Our GRAS Services for Microbial-Derived Ingredients

The development of new microbial-derived ingredients for use in food processing requires an assessment of their safety, including their source, production method, manufacturing technology, and safety studies, which form the basis for determining the GRAS for the intended use.

Identification and Characterization

Microorganisms that undergo large-scale fermentation production often require genetic modifications, such as genetic recombination, to increase productivity. Microorganisms used for the production of ingredients for food additive applications, whether wild-type or recombinant, should be well characterized, non-toxigenic and non-pathogenic.

Manufacturing

BOC Sciences performs microbial fermentation production in accordance with Current Good Manufacturing Practices (cGMP), using food acceptable ingredients and under conditions that ensure controlled fermentation for the production of microbial-derived ingredients. Submerged fermentation (SmF) and solid state fermentation (SSF) are typical manufacturing processes.

Safety assessment

Microbial-derived ingredients are unlikely to pose a safety risk if the producing microorganism has been identified as a safe strain, the technology used for strain improvement is well known and suitable for food use, and the microbial-derived ingredient is well characterized. We are taking a safety assessment approach accepted by the FDA and preparing to submit a GRAS notices to the FDA.

Why Choose BOC Sciences' GRAS Services

• Ensure that the strains used in your project are GRAS-grade
• Provide you with a complete GRAS report
• GRAS service in compliance with relevant regulations
• Premised on current good manufacturing practices (cGMP)
• Assist in the regulatory clearance of microbial components