Recognition of a substance as safe requires reasonable certainty in the minds of competent scientists that the substance is not harmful when used as intended. GRAS self-affirmation requires a complete review and assessment of the safety of the ingredient. The process of achieving GRAS self-affirmation requires a consensus of safety by a panel of experts who are qualified by training and expertise to evaluate the safety of food.
AIBMR Life Science’s experience, knowledge and success with GRAS Self-affirmations is an excellent asset for guiding you through the process. Our expert panel comprises well-respected former senior-level FDA and EPA toxicologists. In addition, our library has many rare publications that are useful when determining the historical usage of ingredients.
We create a detailed, professional GRAS dossier for your product that is signed by the expert panel. The dossier includes a thorough introduction of your product, all available toxicology and safety data, extensive literature reviews and references. When appropriate, we prepare GRAS self-affirmation notifications for FDA review.
The acronym GRAS stands for Generally Recognized As Safe. GRAS ingredients are becoming increasingly valuable as the functional foods market explodes. The FDA’s proposed regulation, issued on April 17th, 1997 created a GRAS self-affirmation and FDA notification procedure. A GRAS determination is made by an expert panel if, after an independent and collective critical evaluation.
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