If you’re in the food business, you’ve likely come across the term “GRAS”, short for “Generally Recognized as Safe.” It’s a key concept in food regulation that identifies substances considered safe for use in food based on expert consensus or historical usage. But what does it really take for an ingredient to earn that recognition, and what role does the GRAS list play in product development and compliance?
Understanding the GRAS list is essential for food manufacturers, suppliers, and regulatory professionals. It helps determine whether an ingredient needs formal U.S. Food and Drug Administration (FDA) approval or can be used based on GRAS status.
In this blog, we’ll walk you through what the GRAS list is, how it works, and how substances are added. Keep reading to learn how this process can impact your product development and compliance strategy.
What are food additives?
Food additives are substances added to foods to improve their taste, texture, appearance, shelf life, or nutritional value. They play an essential role in modern food production by helping ensure that products remain safe, appealing, and consistent during manufacturing, transport, and storage.
For example, preservatives help prevent spoilage, and emulsifiers help stabilize texture. As a result, additives have become a foundational part of our food supply. However, because these substances directly affect what we consume, it is crucial to evaluate and confirm their safety.
This is where the GRAS framework becomes important. It helps manufacturers determine whether an ingredient requires formal FDA pre-market approval or if it can be considered generally recognized as safe based on established scientific procedures or historical use.
What is the GRAS list and how are substances added to it?
The GRAS list is maintained by the FDA. It includes food substances that qualified experts consider safe based either on a long history of common use in food prior to 1958 or on scientific evidence published in peer-reviewed literature.
Specifically, food additives can be added to the GRAS list in two ways:
- Self-determination: In this process, a company conducts its own safety assessment using qualified experts and scientific evidence. The company concludes independently that the substance is GRAS and is not required to inform the FDA. However, the documentation must be thorough and defensible in the event of regulatory scrutiny.
- Petition process (GRAS notification): Alternatively, a company may voluntarily submit a GRAS notice to the FDA. This includes all supporting data and conclusions regarding the ingredient’s safety. The FDA reviews the submission and may issue a “no questions” letter if it agrees with the GRAS determination. The substance is then added to the public GRAS notice inventory.
Both options require a robust safety assessment, clear documentation, and consensus from qualified experts. While the notification process provides greater transparency, both methods are valid paths to achieving GRAS status under FDA guidelines.
Why the GRAS list matters to manufacturers and suppliers
Being able to rely on GRAS status offers several practical advantages. For one, it helps companies and food ingredient suppliers bring new products or ingredients to market more quickly, since substances recognized as GRAS do not require formal FDA approval.
This can be particularly beneficial when managing timelines for innovation or responding to evolving market demands. It also translates into lower regulatory costs, which can be a significant consideration for startups and established businesses alike.
In addition, using GRAS substances can enhance consumer and client trust, since these ingredients have already undergone a recognized safety evaluation. For suppliers, this can mean greater marketability and fewer barriers when selling ingredients to manufacturers.
In contrast, using non-GRAS or unapproved additives can expose businesses to costly enforcement actions, recalls, or reputational harm. But, most importantly, GRAS compliance helps reduce the risk of product recalls or enforcement actions, both of which can damage a company’s reputation and bottom line.
Common GRAS-listed food additives
There are hundreds of food additives included on the GRAS list, ranging from preservatives and color additives to flavor enhancers and emulsifiers. These substances are commonly used across various food categories and have been thoroughly reviewed for safety by qualified experts.
Here are a few ingredients often found on the GRAS list:
- Xanthan gum: Thickener and stabilizer used in sauces, dressings, and baked goods
- Sodium benzoate: Preservative in beverages and condiments
- Aspartame: Artificial sweetener found in diet sodas and sugar-free products
- Caffeine: Stimulant used in drinks
- Titanium dioxide: Color additive used in products like candy, frosting, and chewing gum
These substances are recognized as safe based on extensive scientific evidence or historical use, but it is still essential to evaluate each ingredient for specific applications and populations.
How to pursue GRAS status for an ingredient
If you want your ingredient to be considered GRAS, follow these steps:
- Conduct a thorough safety assessment: Include toxicology, exposure, and intended use.
- Engage qualified experts: Toxicologists and regulatory professionals can support your dossier.
- Document everything: Keep comprehensive records.
- Submit a GRAS notice to FDA (optional but recommended): Gain additional credibility and public listing.
You can search the FDA GRAS Notice Inventory to see if a GRAS notice has been submitted. This can save time and clarify whether you need to initiate a new submission or build on existing data.
FAQs about the GRAS list
Are all safe food additives on the GRAS list?
No. Some additives may be FDA-approved through other regulatory processes.
Can I use an additive not on the GRAS list?
Only if it has been approved through the FDA’s food additive petition process or another recognized pathway.
Is GRAS status permanent?
Not always. The FDA can revoke GRAS status if new safety data emerges.
Can GRAS status vary by intended use?
Yes. A substance may be GRAS for specific uses but not for others.
Is GRAS accepted internationally?
Not necessarily. Other regions have their own safety assessment standards.
How is GRAS status different from FDA approval?
GRAS status is based on scientific procedures or a long history of safe use, while FDA approval involves a formal petition and extensive pre-market review. GRAS substances can be used without going through the full FDA approval process but must still meet rigorous safety standards.
Are there risks with GRAS determinations?
Yes. Critics of the GRAS process point to the potential lack of transparency, especially for self-affirmed GRAS. However, the FDA retains the authority to challenge determinations and can intervene if a substance is later found to be unsafe.
What happens after submitting a GRAS notice?
Once a GRAS notice is submitted, the FDA may issue a “no questions” letter if it agrees with the determination, request additional data, or conclude that the notice does not provide sufficient basis. Regardless of the outcome, the submission becomes part of the public GRAS notice inventory.
Need help navigating the GRAS process?
At Quality Smart Solutions, we help manufacturers, suppliers, and formulators navigate every stage of the GRAS process. Whether you need ingredient classification, support with feasibility assessments, or full GRAS dossier development, our regulatory experts are here to guide you with confidence.
We also assist with a wide range of related services, including Novel Food Notifications, SFCR license applications, HACCP and PCP program development, TMA licenses for Supplemented Foods, Nutrition Facts Table (NFT) creation, and full label compliance reviews.
Talk to our team or explore our food safety and compliance services and ingredient compliance solutions to get started today.
