Self-affirmed GRAS

Our team of compliance experts can help you with the requirements of self-affirmed GRAS (Generally Recognized as Safe), such as determining if GRAS status is necessary for your ingredient, preparing a self-affirmed GRAS dossier, and ensuring that your ingredient meets safety requirements for commercial sale in the US market.

Self-affirmed gras database

Self-affirmed GRAS Overview

With self-affirmed GRAS, a company convenes a panel of professionals to evaluate the safety of a specific ingredient and then informs the FDA (through a “GRAS Notification”) of their findings. With self-affirmation, the FDA then evaluates the information provided in the GRAS notification and responds to the company with their decision on whether or not they agree with the basis of GRAS determination. Nonetheless, the GRAS notification procedure involves a rigorous process and criteria to conclude that the use of a substance in food is safe.

Why GRAS Ingredients are Important

GRAS ingredients ensure safety of the food supply and ultimately, consumers. Non-GRAS food additives require the company to notify the FDA a minimum of 75 days before the food or supplement enters the market. In the notification, manufacturers are required to disclose a wealth of information such as the amount to be consumed, history of the use of the ingredient,  conditions for use and published articles and citations or other evidence that prove that the product containing the non-GRAS ingredient is safe to use. When it comes to GRAS ingredients, no further notification to the FDA is required because the ingredient is already deemed safe to use.

self-affirmed GRAS list

The Experts at QSS can help with self-affirmed GRAS

As a leading scientific and regulatory consulting and compliance firm, we provide assistance with self-affirmed GRAS dossiers and services. Our experienced team assesses the safety of ingredients to be added to foods.

We are able to create a fulsome self-affirmed GRAS dossier for your product. Self-affirmed GRAS contains a complete introduction of your product, extensive literature reviews and references and all available safety data and toxicology.

Frequently Asked Questions

In Self Affirmed GRAS, a company convenes a panel of professionals to evaluate safety of a specific ingredient and then informs the FDA (through a “GRAS Notification”) about their affirmation that the use of a substance is GRAS. With self-determination, FDA then evaluates the information given in the GRAS Notification and responds to the company whether it agrees with the basis of GRAS determination. Nonetheless, the procedures to GRAS involve rigorous processes and criteria to conclude that the use of a substance in food is GRAS.

GRAS ingredients ensure safety of food supply and the safety of consumers. Non-GRAS-approved additives require the company to notify FDA a minimum of 75 days before the food or supplement enters the market. In the notification, manufacturers are required to disclose a wealth of information such as the dose, history of the use of the ingredient, conditions for use, published articles and citations or other evidence that prove that the product containing the non-GRAS ingredient is safe to use. When it comes to GRAS ingredients, it does not involve submitting a GRAS dossier to the FDA because the ingredient is already deemed safe to use.

These ingredients have undergone extensive safety evaluations to be classified as an ingredient that is guaranteed to not cause harm when used as it is supposed to be used.

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