Approval Application for Spermidine-3HCl from Genetically Engineered Saccharomyces cerevisiae for Use in Foods and Supplements under Regulation (EU) 2015/2283

Chrysea Labs, LDA has submitted a novel food application to the European Commission for spermidine hydrochloride (spermidine-3HCl) produced by genetically engineered Saccharomyces cerevisiae strain CHRYSPD3. The ingredient is an off-white to light brown powder with a minimum spermidine-3HCl purity of 90%, and is intended for use in conventional foods (e.g., yoghurts, meal replacement bars), foods for total diet replacement for weight control, and food supplements. The amount provided per serving in these food uses will not exceed 20 mg spermidine-3HCl, equating to approximately 11 mg of spermidine. The ingredient is produced using a fully characterised strain with no viable cells or DNA from the production strain detected in the novel ingredient. The available data support that spermidine-3HCl does not pose a safety concern to humans under the conditions of intended use.