In 1958, the United States introduced the "Food Additives Amendment". The Act stipulates that any food additive must be approved for safety by the FDA before it can be used. Since then, hundreds more have been listed “ Exception” The substance of... These substances are functionally food additives, but because “ High safety ” It is not regulated by the Act. Substances included in this list have either been “ Experts with sufficient scientific background ” The security reviews done are either “ No safety issues are considered after long-term use. . These substances are called “ Generally considered safe ” (Generally Recognized as Safe), GRAS for short.

GRAS is a standard used by the FDA to evaluate the safety of food additives. GRAS certified ingredients are considered safe when used under reasonable conditions and no special food additive certification is required.

There are two different GRAS filing routes that can be used to obtain an application component to achieve GRAS status, with three main differences between the two different filing routes: cost, time, and public accessibility.

FDA-Notified GRAS 

GRAS application process reviewed and notified by FDA. If a substance is considered to be “ GRAS” The FDA can provide “ No objection ” The document can be used for marketing purposes. This is a voluntary application programme that has been in place since 1997.

Expected time: 8-10 months (2 months for dossier preparation and 6-8 months for FDA response).

Public accessibility: Yes, FDA will release the dossier.

Self-Affirmed GRAS

The process by which companies or individuals self-identify as GRAS based on the conclusions of a panel of scientific experts. Companies or individuals are not required to consult the FDA, and the FDA is not required to accept the announcement of the conclusion. However, companies should ensure that their GRAS conclusions meet the criteria for GRAS in FDA's final Rule.

Schedule: 4-6 months (2 months for dossier preparation and 2-4 months for panel evaluation).

Public accessibility: voluntary not mandatory.

Cost: The fee of expert jury will be increased.

1. Fill out the FDA form

2. Prepare GRAS report, which is divided into about 6 parts, including:

① GRAS EXEMPTION CLAIM ② INTRODUCTION ③ CHEMISTRY&MANUFACTURING OF GLUCOSYLATED STEVIA ④ SELF-LIMITING LEVELS OF USE ⑤ REFERENCES ⑥ The full report takes approximately 50-60 pages to fully describe the safety and reliability of the product

3. Wait for FDA audit report

4. GRAS listing if FDA passes without objection