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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.  As we, innovation requires that novel ingredients be proven safety for consumption. 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 notified to the FDA to determine GRAS status.

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How long does it take FDA to respond 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.  FDA will respond to GRAS notice in one of three ways:

1. FDA has no questions or comments for the notifier and the contents of the GRAS dossier.

2. FDA concludes there isn’t sufficient data or that the data raises potential issues that the substance is safe.

3. The notifier requests the FDA to stop evaluating the GRAS notice. 

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. Most GRAS dossiers are self-affirmed.  We can help you prepare a self-affirmed GRAS dossier.

What is GRAS?

GRAS is an acronym that stands for Generally Regarded as Safe.   As The GRAS process is voluntary—but it’s also required in order for companies to use and/or sell certain ingredients in the United States.

A food substance is deemed to be GRAS if has been sold in the United States before 1958 or through scientific evidence as per FDA’s regulations CFR 170.3 and CFR 170.30

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

What are the 7 parts that must be included in a GRAS Notification?

There are 7 sections that must be part of every GRAS Notification filed with FDA.  After a FDA GRAS notice is filed to the FDA either electronically or by paper copy, the first 90 days or review is determining if the GRAS notice meets the administrative obligations.  One element of the administrative requirements of a GRAS dossier includes the 7 sections of a GRAS dossier.  As indicated in Those sections include the following:

Part 1 – Signed Statements and Certification

Part 2 – Identity, Method of Manufacture, Specifications, and Physical or Technical Effect

Part 3 – Target Animal and Human Exposures

Part 4 – Self-limiting levels of use

Part 5 – Experience based on common use in Food before 1958

Part 6 – Narrative

Part 7 – List of Supporting Data and Information in Your GRAS Notice

 

 

What are some examples of GRAS substances?

Many substances are considered GRAS, including common food ingredients like salt, sugar, and vinegar. Other examples of GRAS substances include:
– Ascorbic acid (vitamin C)
– Citric acid
– Calcium chloride
– Glycerin
– Sodium bicarbonate (baking soda)

It’s worth noting that just because a substance is considered GRAS doesn’t mean it’s without risk. However, the risk associated with GRAS substances is generally regarded as low.

GRAS
GRAS Status

Why is GRAS important for food safety?

Understanding GRAS is essential for ensuring compliance with FDA regulations and avoiding potential legal issues if you work in the food industry. If a substance is not considered GRAS and is used in a food product, it may be subject to pre-market approval by the FDA, which can be lengthy and expensive.  

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.

How is a substance designated GRAS?

Determining whether a substance is GRAS is a complex and rigorous process that thoroughly evaluates all available scientific data. At a high level, the method for determining whether a substance is GRAS involves two main steps:
1. Experts in the field evaluate the substance’s safety: A panel of experts in toxicology, chemistry, and other relevant fields assesses the security of the substance based on all available scientific data. This includes data from animal and human studies and data on the substance’s chemical structure, potential toxicity, and other factors.
2. The FDA reviews the data and makes a determination: After the expert panel has evaluated the substance’s safety, the FDA reviews the data and decides whether the substance is GRAS. If the FDA determines that the substance is not GRAS, it may require pre-market approval before it can be used in food products.

What are the costs for GRAS Notification?

There are several costs to consider.  First is that there are various types of toxicological testing requirements to prove the safety of the substance.  It may be possible to use published studies to substantiate the safety but generally, given the uniqueness of substances today which may include manufacturing processes (eg. nanotechnology, fermentation) toxicological studies must be conducted.  These studies can be expensive but there are strategies that can be taken to conduct these studies in an OECD recognized clinical research organization (CRO) that is cost effective.  Other costs to consider is engaging a consultant to prepare and write the GRAS dossier, recruiting an expert panel (not mandatory) and, if required, a meeting with FDA on-site (though most meetings are now done virtually). 

food safety certifications, GRAS Ingredients, EFSA, HACCP, SFCR
European Food Safety Authority (EFSA) Novel Food Pathway

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 to comply 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

What is the difference between GRAS and food additives?

It’s important to note that not all food additives are considered GRAS. Many food additives require pre-market approval by the FDA before being used in food products. The main difference between GRAS substances and food additives is that GRAS substances are generally recognized as safe based on a long history of use in food. In contrast, food additives may be new or have a limited account of food use.

How QSS 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
  • Conduct a gap assessment to determine if sufficient safety evidence is available to determine GRAS of your ingredient
  • Advise on appropriate clinical trial or toxicological testing
  • 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
  • Determine the most appropriate regulatory pathway for your ingredient such as ODI, NDI, GRAS self affirmation or GRAS Notice
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

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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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