Safety Assessment
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.
Navigate the complex regulatory landscape with confidence and ensure your product’s safety and market readiness with GRAS Experts.
We’ve been doing this for over 18 years, with over 2,000 happy clients!
No time to waste! We help you get to the market quickly without compromising quality.
Every ingredient is unique, and so is our approach. We tailor our services to your specific needs.
Safety is our top priority. We make sure your ingredients meet all the requirements.
Avoid costly delays, fines and potential product recalls with our expert guidance.
Regulations can change. We’ll keep you compliant for the long haul.
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