Conduct a thorough evaluation of your ingredient's safety profile, including its chemical composition, potential hazards, and historical use.
Self-Affirmed GRAS (Generally Recognized As Safe) is a designation for ingredients that qualified experts consider safe for their intended use in food, beverages, and dietary supplements. Unlike the FDA-notified GRAS process, Self-Affirmed GRAS does not require submission to the FDA for approval.
It is a process by which you take responsibility for establishing the safety of your ingredient for its intended use in food products. This involves compiling a comprehensive dossier with scientific evidence demonstrating its safety based on established criteria set forth by the US Food and Drug Administration (FDA).
Self-Affirmed GRAS is a valuable option for a variety of businesses, particularly:
Achieving Self-Affirmed GRAS requires a thorough understanding of FDA guidelines and the creation of a robust safety dossier. This process typically involves below steps:
Conduct a thorough evaluation of your ingredient's safety profile, including its chemical composition, potential hazards, and historical use.
Engage qualified experts to assess the data gathered from the safety assessment and ensure its sufficiency in demonstrating safety for its intended use.
Develop a comprehensive dossier outlining the scientific rationale for your ingredient's safety. This document should include all relevant data, expert evaluations, and supporting documentation.
Self-Affirmed GRAS is an ongoing process that requires maintaining thorough records of the entire process and associated documentation. This documentation serves as a critical reference point for future use and potential inquiries from regulatory authorities. Be prepared to readily provide this documentation upon request to demonstrate the safety assessment and rationale behind your Self-Affirmed GRAS conclusion.
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