Abstract
Food Safety Commission of Japan (FSCJ) conducted a safety assessment on a food additive: flavoring "Valencene", which is produced using Rhodobacter sphaeroides 168 strain based on documents mainly submitted by the applicant. Safety of the inserted genes including toxicity and allergenicity of the proteins produced from the inserted genes, recombinant and host protein residues, and others were evaluated based on the guideline. In the evaluations no risk due to use of recombinant technology was found in the bio-production of "Valencene". From the identified chemical structures, toxicological findings and also estimated intakes of non-active ingredients detected in "Valencene", none of safety issues were expected for them. From the above evaluations, FSCJ concluded that no concern relevant to human health is raised on the food additive, "Valencene" produced using Rhodobacter sphaeroides 168 strain.