Introduction:
If you’re a food manufacturer, you need to understand the generally recognized as safe (GRAS) process. This process determines whether a substance is safe to use in food products without the need for pre-market approval from the FDA. This guide will provide you with a comprehensive overview of the GRAS process, including its history, requirements, and benefits.
What is the GRAS process?
The generally recognized as safe (GRAS) process is a way for food manufacturers to determine whether a substance is safe to use in food products without the need for pre-market approval from the FDA. This process was established in 1958 as part of the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. The GRAS process involves a thorough evaluation of the available scientific data on a substance to determine its safety for use in food products. If a substance is determined to be GRAS, it can be used in food products without the need for pre-market approval from the FDA.
Who regulates the GRAS process?
The GRAS process is regulated by the U.S. Food and Drug Administration (FDA). The FDA is responsible for ensuring the safety of the food supply in the United States, and the GRAS process is one way that they do this. The FDA provides guidance to food manufacturers on how to conduct a GRAS evaluation, and they review the safety data submitted by manufacturers to determine whether a substance is GRAS. It’s important for food manufacturers to follow the FDA’s guidance and regulations when conducting a GRAS evaluation to ensure the safety of their products.
What are the requirements for a substance to be considered GRAS?
To be considered GRAS, a substance must meet two requirements. First, it must be generally recognized, among qualified experts, as safe for its intended use. This means that there must be a consensus among experts in the field that the substance is safe for use in food. Second, the safety of the substance must be supported by scientific evidence. This evidence can come from a variety of sources, including published studies, historical use of the substance in food, and other relevant data. Food manufacturers must provide this evidence to the FDA as part of their GRAS evaluation.
How to conduct a GRAS determination?
Conducting a GRAS determination involves a thorough evaluation of the safety of a substance for its intended use in food. This evaluation should be conducted by qualified experts in the field, who will review all available scientific evidence to determine whether the substance meets the requirements for GRAS status. The evaluation should include a review of published studies, historical use of the substance in food, and any other relevant data. Once the evaluation is complete, the results should be documented in a GRAS determination report, which should be submitted to the FDA for review.
What are the benefits of obtaining GRAS status for your food ingredient?
Obtaining GRAS status for your food ingredient can provide several benefits for your business. Firstly, it can help to increase consumer confidence in your product, as it demonstrates that your ingredient has been thoroughly evaluated for safety. This can be particularly important for new or innovative ingredients that may be unfamiliar to consumers. Additionally, having GRAS status can help to streamline the regulatory process, as it can reduce the need for additional safety testing or documentation. Finally, it can provide a competitive advantage in the marketplace, as it can differentiate your product from others that do not have GRAS status.
For more information on self-affirmed GRAS and what achieving the Generally Recognized as Safe (GRAS) could mean for your food products contact us for a complimentary consultation.
Additional Reading about GRAS:
- Gras Certification in the Food Industry
- Benefits of a Self-Affirmed GRAS Dossier for your business
- FDA GRAS Status
- GRAS List for Food Additives food safety
- Everything to know about GRAS Ingredients
- Generally Recognized as Safe GRAS Guide
- FDA GRAS Notice & GRAS Database
- NDIN vs GRAS Certification
- GRAS, NDI, ODI Food Additives Unlocked
FAQs
What is the GRAS process?
The GRAS process (“Generally Recognized as Safe”) allows food manufacturers to determine that an ingredient is safe under its intended use without needing pre-market approval from the FDA. It’s based on scientific data and/or long history of safe human use.
What criteria must a substance meet to be considered GRAS?
Two main criteria:
• General recognition among qualified experts that the substance is safe for its intended use.
• Scientific evidence supporting its safety, which can include published studies, historical use in foods, toxicology data, etc.
What is involved in conducting a GRAS determination?
Key steps include:
• Gathering all relevant safety data animal studies, human trials, historical use, published literature.
• Having qualified experts review the data.
• Documenting the evaluation in a detailed GRAS determination report.
• Submitting a GRAS notification to the FDA (if desired) or choosing self-affirmed GRAS status.
What are the benefits to manufacturers of achieving GRAS status for an ingredient?
Some of the benefits are:
• Streamlining the regulatory process by avoiding premarket approval for food additives.
• Building consumer confidence via a recognized safety evaluation.
• Gaining competitive advantage when using novel or unfamiliar ingredients, by showing their safety via GRAS.
What does self-affirmed GRAS vs FDA GRAS Notification mean, and how do they differ?
- Self-affirmed GRAS: The manufacturer themselves undertakes the safety evaluation, engages qualified experts, and documents the conclusion internally. No formal FDA review required, but the evidence must be robust.
- FDA GRAS Notification: The manufacturer submits the GRAS determination to the FDA; FDA reviews it. If FDA doesn’t raise concerns, this adds a level of external validation. It offers more regulatory clarity, but requires more documentation and may persuade stakeholders with higher confidence.
