Florida-based manufacturer of botanical extracts HP Ingredients has revealed its Bergamonte bergamot extract has achieved GRAS (generally recognised as safe).
The independent conclusion was based on an large body of scientific literature including pre-clinical and human studies and illustrated the cardiometabolic and cardiovascular benefits of the extract.
Obtaining self-affirmed GRAS for Bergamonte was years in the making
Speaking about the regulatory landmark, HP Ingredients’ CEO Annie Eng said: “We have been able to prove its safety and its efficacy for the claims on the ingredient, and now with self-affirmed GRAS status, our brand partners and their consumers can enjoy knowing that Bergamonte is, without a doubt, safe for consumption. Obtaining self-affirmed GRAS for Bergamonte was years in the making.”
Manufacturers have the choice to submit a GRAS notification petition to the Food and Drug Administration (FDA), or alternatively, come to their own determination while using using an independent panel and making public the subsequent report.
Eng continued: “Our FDA experts found that the data on the extensive use of Bergamot in food in large populations in numerous areas fully satisfies this requirement.”
The report “strongly affirmed” the long histroy of Bergamot in food, beverages and supplements in widespread populations and the reasonable certainty of safety for its intended use.
