GENERALLY RECOGNIZED AS SAFE (GRAS) NOTIFICATION SERVICES
Generally Recognized As Safe (GRAS) status is a designation by the FDA that a substance added to food is considered safe by experts. This status allows ingredients to be used in food products without the need for further pre-market review and approval by the FDA.
Achieving GRAS status is crucial for companies looking to introduce new food ingredients into the market. It assures consumers and regulatory bodies of the ingredient’s safety and can enhance market acceptance. The process of achieving GRAS status involves a thorough review of scientific data and literature to demonstrate the ingredient’s safety. This typically includes a comprehensive scientific review, preparation of a GRAS notification, and submission to the FDA for evaluation.
At Rejimus, we offer comprehensive GRAS services to help you navigate the process of achieving GRAS status. Our experts will guide you through evaluating scientific evidence, preparing necessary documentation, and submitting your GRAS notification to the FDA.
Our services include:
• Assessing ingredient development and regulatory strategies and requirements
• Literature reviews and research inclusive of all scientific data, protocols, and supporting documentation
• Toxicological study and data reviews
• Dossier preparation for either Self-affirmation or Expert Panel Review (including Panel Assembly and Moderation)
• Notification submission to the FDA and Response Support
• Dedicated Project Management Platform with Client-side access
Our GRAS Notification process involves several steps. First, we conduct an initial consultation to understand your ingredient and its intended use. Next, we perform a scientific review, analyzing existing research and data. We then prepare the necessary documentation, drafting and compiling the GRAS notification. Finally, we submit the notification to the FDA and address any feedback received. It must be noted that the FDA’s timeline in response to a GRAS Notification submission can generally take up to 180 days, but can be extended an extra 90 days at the discretion of the FDA. The benefits of achieving GRAS status include a streamlined regulatory approval process, enhanced consumer trust and marketability, and compliance with FDA regulations.
Current GRAS – FDA GRAS Inventory List