GRAS (Generally Recognized as Safe) Notification

Our US compliance experts can analyze your food ingredients, determine whether FDA GRAS notification is possible, then prepare a well-organized dossier for submission to the FDA to ensure your ingredient qualifies for sale in the US.

US FDA GRAS Database

GRAS Notification Overview

“GRAS” is an acronym for ‘Generally Recognized As Safe.’ Any substance to be added to a food product in the US must obtain a GRAS status before it (the substance) is added to the product. GRAS status is given to the proposed use of an ingredient. In general, two separate ways can be adopted to obtain GRAS recognition.

  1. A GRAS Notification – With GRAS Notification to the FDA, the government issues a letter after an assessment is conducted.
  2. Self GRAS Determination – With this method, the FDA is not involved. The stakeholder is solely liable for verifying safe use with the review of an expert panel.

A self-determination GRAS dossier follows all of the same steps as a GRAS notification and format with the exception that the dossier is not submitted to the FDA. The majority of GRAS dossiers are self-affirmed.  We can help you prepare a self-affirmed GRAS dossier.

FDA Response to GRAS Notification

The FDA responds to GRAS Notifications within 180 days from the date of original filing. However, the Authority also reserves the right to extend the review timeline by 90 days. So the total number of days can be 270.

How We Can Help You With The GRAS Notification Process

Our skilled team can help you navigate through the complex GRAS Notification process by assisting with the entire paperwork submission. We will:

  • Determine whether GRAS status is required for your ingredient
  • Help with a successful regulatory strategy
  • Detect scientific and technical data gaps and suggest solutions
  • Conduct research for scientific evidence to ensure substance is safe 
  • Prepare and submit GRAS notifications and liaison with the FDA
  • Mediate expert panel reports on GRAS conclusions
FDA GRAS Guidance

Frequently Asked Questions

FDA responds to GRAS Notifications within 180 days from the date of original filing. However, the Authority also reserves the right to extend the review timeline by 90 days. So, the total number of days is 270.

“GRAS” is an acronym for ‘Generally Recognized as Safe.’ Any substance to be added to a food product in US must obtain a GRAS status before it (the substance) is added to the product.

A GRAS Notification provides a voluntary mechanism whereby a person may inform the FDA of a determination that the use of a substance/ingredient is generally recognized as safe.

A self-determination GRAS dossier follows all the same steps as a GRAS notification and format with the exception that the dossier is not submitted to the FDA. Most GRAS dossiers are self-affirmed.  We can help you prepare a self-affirmed GRAS dossier.  

Self GRAS Determination – In this method, FDA is not involved. The stakeholder is solely liable for verifying safe use with the review of an expert panel.

Our expert team is skilled to help you navigate through the complex GRAS Notification process by assisting with the entire paperwork submission. Our services include:

  • Determine whether GRAS status is required for your ingredient
  • Help with a successful regulatory strategy
  • Detect scientific and technical data gaps and suggest solutions
  • Research for scientific evidence to ensure substance is safe 
  • Prepare and submit GRAS notifications and liaison with FDA

Mediate expert panel reports on GRAS conclusions

Need Expert Help with GRAS Notifications?

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