US FDA GRAS Application

Updated on November 11, 2024

Introduction

“GRAS” is an acronym for the phrase Generally Recognized As Safe, which stands as an important food regulatory category in the United States. Simply speaking, if a substance is generally recognized to be safe under the conditions of its intended use among qualified experts through scientific procedures, it can be recognized as GRAS.

Boasting widespread recognition internationally, GRAS has become a gateway for enterprises to access global markets.

Types of GRAS certification

Self-affirmed GRAS:

It only requires recognition from qualified experts demonstrating the safety of the substance, without submitting a notice to the FDA and without undergoing FDA review, thus it will not be publicly disclosed.

FDA GRAS Notice:

Formal submission to the FDA is required, followed by an official FDA review. After receiving the response of “FDA has no questions”, substance approved will be added to the GRAS list and made available on the official website of FDA for verification. Generally speaking, compared with self-affirmed GRAS, it is more authoritative and enjoys wider recognition.

Who can apply for GRAS application?

Any individual or institution is encouraged to make a submission to the GRAS notification program, explaining that a substance qualifies as GRAS, thus exempting it from pre-market approval procedures required by US law.

Procedures for GRAS application

Note: Steps 1 to 5 are the general procedures for self-affirmed GRAS, while steps 6 to 10 are required for FDA GRAS.

Required materials for GRAS application

The following materials are generally required from businesses for data analysis:

1) Basic information including substance identity, common name (if has), chemical name or synonym, trade name, chemical structure, and relative molecular mass, etc;

2) Intended conditions of use and use level of the substance in food;

1. Production process;
2. Product specification and relevant Certificate of analysis (COA);
3. Self-limiting level in food;
4. Historical consumption; and
5. Safety description

Estimated timeframe

Our services

• US FDA GRAS application consultation and training
• Self-affirmed GRAS
• FDA GRAS Notice
• FDA NDI Notification

Further Information

Frequently Asked Questions on FDA Generally Recognized As Safe (GRAS) Certification, Vol. 2