GRN 729 Response Letter

Our product, "Galacto-oligosaccharide (GOS),"

has received GRAS certification in the United States.

We kindly ask for your great interest.

GRAS (Generally Recognized As Safe) refers to substances that are directly or indirectly incorporated into food or affect the characteristics of food, and are generally approved as safe based on scientific review by experts.

Substances subject to GRAS review encompass the majority of areas within the concept of food additives and can substantially include most substances not classified under new chemical synthetics or heterogeneous usage categories.

There are two main procedures for GRAS certification: "Self-affirmed GRAS," where a company can evaluate safety independently and sell without prior petition to the FDA, and "notified GRAS," which allows for sale after undergoing a petition process similar to that for additives, submitted to the FDA before market release.

For Self-affirmed GRAS, manufacturers can sell substances recognized as GRAS without FDA approval; however, the manufacturer bears full responsibility for the recognition, and the FDA may withdraw GRAS status if deemed necessary for public health. Moreover, preference and acceptance of Self-affirmed GRAS are generally low from the perspective of food companies and other users.

In our case, we obtained certification through notified GRAS by submitting relevant data for review and verification to the FDA.