Generally Recognized as Safe (GRAS), Food Contact Notifications (FCNs) and Food Additive Petitions: Comprehensive Design and Submission

GRAS, which stands for Generally Recognized As Safe, is a designation by the Food and Drug Administration (FDA) for substances added to food. It means that qualified experts generally recognize a substance as safe for its intended use, based on scientific procedures or experience based on common use in food. GRAS substances don’t require pre-market approval from the FDA.

Visit our Frequently Asked Questions page to answer the questions you may have.

Before a substance can be legally added to food in the U.S., with rare exceptions, it must be either an approved food additive, prior-sanctioned, or determined to be generally recognized as safe for use in human and animal food. Today, many people choose the GRAS option as the way to meet this requirement.

The GRAS route offers two options, GRAS Notification, where a prepared notice is submitted to FDA for review and comment; or Independent (self) GRAS conclusion where the stakeholder makes the determination that the use of the substance is GRAS.

Both options require diligent study assessments of the feasibility and safety of the ingredient in question.

GRAS Frequently Asked Questions

EAS Consulting Group, LLC has a long and successful history of leading companies through the GRAS process. EAS has expert consultants in the areas of toxicology and regulatory requirements to take you through the steps of a GRAS determination, from study design, identification of a qualified Contract Research Organization, study oversight and preparation of GRAS submission.

Choose EAS for:

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Determination of required performance outcomes and appropriate studies to demonstrate

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Development of study design and protocols

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Identification of an appropriate Contract Research Organization (CRO)

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Coordination of the study initiation and management oversight with the CRO

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On-going monitoring of study protocols and outcomes

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Provide input of appropriate data for inclusion in study reports

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Support the writing of the dossier for FDA submission

If the GRAS option is not feasible or preferred, EAS can help you with other options, e.g., food additive petition, food contact notification (FCN), the threshold of regulation, etc.

Related Resources

FDA Submissions for Human and Animal Food Ingredient and Packaging Safety