GRAS Microorganisms

Introduction of GRAS Microorganisms

To ensure the safe use of food additives, FDA approval of Generally Recognized as Safe (GRAS) substances for specific uses needs to be followed. For the food industry to use a new additive or an approved additive for a different purpose, the manufacturer must first apply to the FDA for approval. The GRAS process is well suited for food and animal feed. Food additives can be microorganisms and microbial-derived ingredients. In the food industry, microorganisms play different roles through fermentation. Fermentation is a metabolic process that derives energy from organic compounds. For example, the formation of inhibitory metabolites such as bacteriocins to preserve food and the removal of toxic compounds to improve food safety.

BOC Sciences performs safety evaluations of microorganisms in food additives. We have the CNAS accredited laboratory with extensive experience in strain identification and preparation of GRAS documents. Our team of GRAS experts in microbiology is able to act as a liaison with the FDA for the preparation of GRAS filings to meet the needs of our clients' food additive-related projects.

GRAS-microorganisms in different uses

Ensuring the Safety of Microorganisms

Elements that must be considered when conducting a safety evaluation of a microorganism include the technology used, the production strains, the manufacturing process, safety studies, etc.

Safety of strain improvement techniques

In industries including food, pharmaceutical and nutritional products, host strains are often genetically modified to make them suitable for industrial fermentation conditions and to increase their productivity. Strain improvement techniques include recombinant DNA technology, gene mutagenesis, transfection, directed evolution, etc. These genetic engineering techniques are used to modify the host in order to obtain a fast growing, genetically stable, and non-toxic strain for humans. In strain improvement, it is necessary to consider: the safety of the inserted exogenous DNA and transfection techniques, the safety of the plasmid vector, the elements required for the replication, selection and expression of the gene sequence, etc.

Safety of production strains

Methods used to demonstrate the safety of host strains include:

(1) By ensuring that the host strain is non-pathogenic and non-virulent, e.g., by selecting the use of safe non-genetically modified organism (Non-GMO).

(2) By establishing a safe strain profile through genetic engineering techniques.

The safety of the host strain will be supported by safety data including toxicology studies. In addition, the host strain must not cause disease in healthy humans or animals, i.e., it must not be pathogenic and toxigenic.

Methods used to demonstrate the non-toxicogenicity of host strains include:

(1) By analysis of the genome sequence, in particular identification of the toxin gene.

(2) By studying the known toxin-encoding genes of the strain to determine whether toxic secondary metabolites are produced under manufacturing conditions.

(3) By assessing the level of toxin produced by the strain to determine if it has adverse effects in the intended use.

Our Services for GRAS Microorganisms

• Safety evaluation of the microorganism to demonstrate that the ingredient is generally recognized as safe (GRAS).
• Rigorous execution of microbial genetic modification to provide technical support for the GRAS status of the microorganism.
• Identification of microbial strains and preparation of GRAS documentation.

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 good manufacturing practices (GMP)
• Assist in the regulatory clearance of microbial components