Notification for Establishment of Self-Affirmed GRAS Status for Multifunctional Calcium Silicate FLORITE®
Tomita Pharmaceutical Co., Ltd. has established the status of self-affirmed GRAS (generally recognized as safe) for unique multifunctional Calcium Silicate “FLORITE® R” and “FLORITE® PS-10” in the United States.
The process of self-affirmed GRAS applies to novel food additives or newly intended use of existing food additives, providing assurances of safety as a food ingredient, through exhaustive review by independent toxicological experts in the United States.
Calcium Silicate is approved as GRAS as anticaking agent, and used to be utilized within 2% for all foods or 5% for baking powder.
Our FLORITE® has both capabilities for excellent liquid absorbency and compressibility in different with other conventional Calcium Silicate. In particular, it has been expected in carrying and powderization for liquid ingredients utilized such liquid absorbency.
By the establishment of Self-Affirmed GRAS Status, “FLORITE® R” and “FLORITE® PS-10” can now be utilized as a liquid carrier in dietary supplement at use levels of up to 50% of Calcium Silicate by weight of the dietary supplement in the United States.
We are excited with that dietary supplement manufacturers in the United States can apply “FLORITE®” as liquid carrier into their products, and will strengthen the sales activity of “FLORITE®” in the United States and European market.