Self-affirmed GRAS

We enable you to handle every requirement for self-affirmed GRAS, such as determining if GRAS status is necessary for your ingredient, preparing a self-affirmed GRAS dossier, ensuring that your ingredient meets safety requirements for commercial sale in US market.

Self-affirmed GRAS Overview

Self-affirmed GRAS Overview

In Self Affirmed GRAS, a company convenes a panel of professionals to evaluate safety of a specific ingredient and then inform 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 or not it agrees with the basis of GRAS determination. Nonetheless, the procedures to GRAS involve a rigorous process and criteria to conclude that the use of a substance in food is GRAS.

Why the Need for GRAS Ingredients

GRAS ingredients ensure safety of food supply. It ensures 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 require 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 GRAS dossier to FDA because it is already deemed safe to use.

Prepare Self-affirmed GRAS with the Help of QSS Experts

As a leading scientific and regulatory consulting and compliance firm, we provide Generally Recognized as Safe (GRAS) Self-Affirmed studies and services. Our experienced team assesses the safety of ingredients to be added to foods. They are competent in a complete review and assessment of the safety of the ingredient. 

We are able to create an absolute GRAS dossier for your product. The Self-affirmed GRAS contains a complete introduction of your product, extensive literature reviews and references, all available safety data and toxicology. When required, we can help you prepare GRAS self-affirmation notifications for FDA review.

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