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GRAS (Generally Recognized as Safe) Notification

Food manufacturers are always on the lookout for ways to improve their products. While ingredients like sugar, chocolate, and vanilla have been around for centuries, there are other ingredients that aren’t quite so old but are still valuable to modern food makers. In this article, we’ll cover everything you need to know about FDA GRAS certification: what it is, how it works, and why you should consider getting your ingredients certified by the FDA as GRAS substances.

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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.

What is GRAS?

ingredients that they have determined to be safe for human consumption. As you might imagine, this process is voluntary—but it’s also required in order for companies to sell certain products in the United States.

GRAS notification is different than GRAS status. A company can send the FDA evidence that their product is GRAS through a voluntary notification process (or VNP), but only if they have received approval from their local regulatory agency first. For example, the FDA has not yet determined whether CBD oil is safe enough to consume as a food ingredient, so there are no VNPs on file at this time.

FDA GRAS Guidance
GRAS Substances
Understanding the Different Categories of GRAS Substances:

The FDA recognizes three categories of GRAS substances: those that the FDA has declared generally safe, those that have scientific consensus from expert panels, and those ingredients determined to be GRAS by independent sponsors who evaluate a substance’s safety and then submit evidence to the FDA for review. All three categories must meet the same criteria for safety. It is important to understand the different types of GRAS in order to properly list them on your product label.

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.

GRAS Status

What is the GRAS Affirmation Process?

The GRAS affirmation process is the first step towards taking your product global.

GRAS is an acronym that stands for “Generally Recognized as Safe.” It’s a designation that the FDA uses to define ingredients that are safe for human consumption, but it’s often misunderstood to mean that an ingredient is safe. In fact, GRAS refers primarily to the status of an ingredient—not its safety. An ingredient can be safe even if it isn’t GRAS (or if one or more countries don’t recognize its GRAS status).

FDA certification of your product will almost certainly require you to submit documentation on how you determined that your food ingredient is not harmful at levels expected in foods. If you did not conduct any safety studies prior to launching into the market with this new component, you may need additional testing done before applying for FDA certification.

GRAS Status

GRAS status can also be a self-affirmed status. It is not a regulatory requirement, and it does not have to be registered with or approved by the FDA. In fact, with self-affirmed GRAS, the agency has no record of any product ever being registered with them for use as ingredients in foods, drugs or cosmetics. As mentioned earlier, the GRAS process was established back in 1958 to allow manufacturers to determine whether or not their ingredients are generally recognized as safe for their intended use. The easiest way to explain this process is by comparing it to other voluntary programs that companies may be involved with.

Under this voluntary program, businesses register their products with health agencies before they can sell them commercially. This helps ensure they meet certain safety requirements (for example what potential allergens might be present). Companies who opt out of registration risk being banned from selling their products if found unsafe after launch; however, these regulations do not apply to foods so there’s no need for every food manufacturer out there today to use GRAS ingredients unless they want one!

GRAS Affirmation Process
GRAS Ingredients

Review the List of GRAS Substances and Identify Ingredients that aren't GRAS

To ensure that you are listing all GRAS substances accurately and correctly on your product labeling, be sure to review the FDA’s comprehensive list of recognized ingredients. This list contains more than 3,000 common and essential chemicals, as well as microbial organisms and enzymes that have been determined to be generally recognized as safe for use in various types of food products. By carefully studying this list and comparing it with the ingredient list of your food product, you can make sure that all necessary GRAS substances are listed properly.

Some substances are not considered to be GRAS. While some of these substances may appear on your finished product’s ingredient list, they must not be identified as GRAS. Examples of non-GRAS ingredients include food additives, flavorings, coloring agents, sweeteners, preservatives, and natural flavors. To ensure compliance with industry regulations and safety standards, make sure that the proper wording is used to identify non-GRAS ingredients on your labeling.

Why is GRAS Important?

FDA GRAS certification is important because it allows you to sell your food product in the US. The FDA has a process for certifying ingredients as GRAS. The FDA will not approve a new ingredient for use in food until it has been proven safe, and that process includes submitting data about your ingredient to the FDA and answering any questions they may have about it.

The first step is to submit your data to the FDA, who will review it and ask questions if they’re unsure of anything. This formal review happens after you’ve submitted your information, but before they make their final decision on whether or not something is considered GRAS, so if there are still any unanswered questions at this point then they’ll go ahead with another round of questioning so that everyone feels confident that all potential risks have been taken into account (or at least minimized). Once everything seems good enough on paper then they’ll give their final word!

This certification is an important step for companies looking to expand their product lines or reach a wider audience. The FDA GRAS certification process can be daunting, but when completed successfully can open new doors for your business. Our team has worked with clients across the globe on their GRAS submissions and we have helped them achieve success. If you are interested in learning more about our services or want help getting started on your own submission, please contact us today!

They must pass FDA safety reviews and are approved for food use that meets specific requirements. GRAS is important to understand because it can affect the labels on your food product. Labeling should list all substances with GRAS status, such as “GRAS Flavors” or the individual ingredient names on their label. Understanding how these ingredients impact your labeling is essential for compliance with FDA rules and regulations.

Complying with Food Labeling Requirements When Using GRAS Ingredients:

The FDA requires that all GRAS (generally recognized as safe) ingredients must be clearly identified on the finished product’s labels. This ensures that manufacturers can accurately report which ingredients have been used in the product and, more importantly, it enables customers to make knowledgeable decisions about their dietary choices. Additionally, GRAS ingredients must also be accompanied by an affirmative statement of safety as established through scientific procedures. When labeling products containing GRAS ingredients such as preservatives and flavorings, businesses should include a declaration indicating the identity of each ingredient listed and its function in the food product.

Food Labeling Requirements GRAS Ingredients
GRAS Preservatives

Which Foods Contain GRAS Preservatives?

As a rule, most foods that contain preservatives have been granted GRAS status by the FDA. For example, baked goods like bread and cakes are generally safe for consumption because of ingredients such as sodium benzoate, which is used to keep mold from growing on foods. Canned foods such as sauces may also contain sodium benzoate or potassium sorbate to prevent spoilage. Chocolate and cocoa products like chocolate milk often contain the artificial sweetener aspartame or sucralose for preservation purposes, while other dairy products like cheese slices are preserved through lactic acid cultures such as Lactobacillus rhamnosus GG (LGG).

However, not all foods containing GRAS preservatives are widely available at supermarkets due to limited demand in certain areas of the United States or other countries around the world; instead, they’re usually only available at specialty stores or online retailers located within those particular regions where they’re sold most commonly today

How We Can Help You With Our GRAS Notification Food Classification Services

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
  • Self-affirmed GRAS compliance
  • Choosing between ODI, NDI, GRAS food certification
GRAS Notification

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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