Step-by-Step Guide to U.S. FDA GRAS Certification

Introduction

The United States, as the world’s largest food consumer market, reached a retail food sales value of $1.67 trillion in 2023, and is projected to grow to $2.04 trillion by 2028. This massive and rapidly expanding market offers immense opportunities for global food and ingredient companies—along with increasingly stringent regulatory requirements.

One of the key regulatory frameworks governing the safe use of substances in food is the GRAS system—Generally Recognized As Safe. Understanding what constitutes a GRAS substance, how to apply for certification, and what documentation is required is crucial for food companies aiming to enter or expand within the U.S. market.

What Is GRAS?

Generally Recognized as Safe (GRAS) substances are recognized as safe for their intended use by scientifically trained, experienced, and qualified experts through scientific evaluations.

GRAS certification by the United States Food and Drug Administration (FDA) is a recognition method for food additives, indicating the additive is widely accepted as safe and can be used in food.

GRAS substances can be categorized based on their intended use:

• Direct food ingredients (most commonly referred to when discussing GRAS)
• Indirect food additives (e.g., from packaging)
• Ingredients for animal food and feed
• Others

In industry practice, “GRAS substances” typically refer to direct additives in human food.

What Is GRAS Certification?

GRAS certification allows a substance to bypass FDA’s premarket food additive approval process if it meets the criteria for general recognition of safety. This offers a compliant pathway for introducing food ingredients into the U.S. market without requiring formal approval as a food additive.

According to U.S. law, any substance intentionally added to food is considered a food additive unless:

• It is generally recognized as safe (GRAS) by qualified experts, or
• It falls into other exemption categories (e.g., pre-1958 approved substances, color additives, dietary supplement ingredients)

Therefore, GRAS status serves as an alternative compliance pathway to premarket approval for food additives.

How to Obtain GRAS Certification?

There are two primary GRAS pathways available to individuals or organizations:

1. Self-Affirmed GRAS (Self-Determined GRAS)

The applicant assembles an independent panel of qualified experts to evaluate the safety of the substance and issue a signed consensus statement. The GRAS dossier is not submitted to the FDA, and the conclusion remains confidential.

Although legally valid, self-affirmed GRAS does not offer the same level of market transparency or regulatory credibility as an FDA-reviewed GRAS.

2. FDA-Notified GRAS (GRAS Notification to FDA)

The applicant submits a comprehensive GRAS dossier to the FDA, which is reviewed by agency experts. If no safety concerns are raised, the FDA issues a “No Questions” letter, publicly confirming it does not object to the GRAS conclusion.

This option provides stronger market confidence and is especially recommended for companies exporting to the U.S. or working with major retailers.

Timeline for GRAS Certification

Self-Affirmed GRAS:

• Estimated Time: 6–9 months
• Does not include testing time
• Faster, confidential, but lacks FDA validation

FDA-Notified GRAS:

• FDA review alone takes 6–9 months
• Total process: 1.5–2 years
• Publicly listed in the FDA GRAS database

What Materials Are Required for a GRAS Dossier?

Whether pursuing a self-affirmed or FDA-notified GRAS route, companies must prepare a full English-language technical dossier, typically organized into seven key modules:

1. Cover Letter and Declaration

• Applicant and contact information
• Statement of intended use and request for review

2. Substance Identity and Specifications

• Chemical name, molecular formula, structural formula
• Composition and physicochemical properties
• Manufacturing process and flowchart
• Raw material sources
• Product specifications and analytical reports
• Stability and shelf-life data
• Intended technical effect and effective usage level

3. Dietary Exposure Assessment

• Estimated daily intake (EDI)
• Use levels in various foods
• Population groups and consumption data
• Comparison with existing exposure sources

4. Self-Limiting Levels (if applicable)

• Explanation of whether flavor, odor, or technical limitations restrict use at higher levels

5. History of Use in Food (Pre-1958)

• Historical consumption data for legacy GRAS substances

6. Safety Narrative and Toxicological Evaluation

• ADME (absorption, distribution, metabolism, excretion) data
• Animal studies (acute, subchronic, genotoxicity)
• Human clinical data, if available
• Safety margin and NOAEL analysis

7. Supporting Documentation

• Peer-reviewed studies
• Expert panel report
• Certificates of analysis
• References and scientific literature

Our Services

1. Self-affirmed GRAS

2. FDA notified GRAS

3. Consulting services related to GRAS certification application

Why Partner with REACH24H?

At REACH24H, our dedicated food compliance team has in-depth experience in GRAS dossier preparation and submission. We offer a one-stop service, including:

• Regulatory feasibility analysis
• Data evaluation and testing coordination
• Expert panel organization
• Dossier drafting and FDA interaction support

Whether you’re planning to enter the U.S. market or strengthen your global regulatory compliance, we’re here to help.

Contact us for a tailored consultation and start your GRAS journey with confidence.