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.
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Self-affirmed GRAS, also known as GRAS self-certification, allows businesses to independently establish an ingredient’s safety for its intended use without FDA review. This approach offers several advantages, such as a quicker path to market, reduced upfront costs, and complete ownership of your safety data. By adhering to FDA standards internally, businesses can maintain flexibility and avoid delays typically associated with FDA notifications, streamlining the regulatory process.
The self-affirmed GRAS certification process typically takes 3 to 6 months, depending on the complexity of the ingredient and the availability of safety data. This timeline includes gathering scientific studies, scheduling expert panel reviews, and preparing the GRAS dossier. Partnering with regulatory experts can help you avoid delays and ensure your documentation meets FDA standards.
The letter of certification is a formal statement from an independent expert panel confirming that your ingredient meets FDA GRAS standards. It serves as a critical component of your GRAS dossier, demonstrating that the ingredient has been thoroughly evaluated and deemed safe for its intended use. This letter not only supports regulatory compliance but also strengthens your position if your GRAS status is ever questioned by authorities or industry stakeholders.
The expert panel plays a vital role in establishing GRAS certification by independently evaluating your safety data and determining if the ingredient meets FDA standards. Their scientific expertise ensures the safety assessment is credible and aligned with regulatory requirements. The panel’s written evaluation becomes a key part of your GRAS dossier, solidifying your certification and demonstrating compliance.
Self-affirmed GRAS is recognized primarily in the U.S., but international markets often require additional regulatory approvals. For example, EFSA or Health Canada may demand further safety evaluations for compliance.
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