GRAS Certification
GRAS certification, which stands for "Generally Recognized As Safe," is an international standard proposed and regulated by the U.S. Food and Drug Administration (FDA) to assess the safety of products such as food, food additives, and cosmetic ingredients. This certification means that a substance is considered safe under its intended conditions of use and is widely accepted for use in relevant products. Once a substance successfully passes GRAS certification, it is automatically exempt from the FDA's pre-market review and approval process for food additives, allowing it to be used in food products in compliance with regulations.
The core authority for GRAS certification is the U.S. FDA, but the evaluation process can be conducted by the enterprise or a third-party organization. The applicant is required to submit scientific data to demonstrate the safety of the substance. If it meets the standards after peer expert review, it will be recognized as GRAS status. Scientific evidence, including published research literature, toxicological experimental data, and records of historical use, forms the basis for the evaluation of GRAS certification.
GRAS certification is widely applied in the fields of food, cosmetics, and pharmaceutical excipients. In the food industry, GRAS certification is often used in the approval of new sweeteners and preservatives. In the cosmetics sector, it ensures that ingredients are non-irritating and non-toxic to the human body. For instance, when a brand launches skincare products containing plant extracts, GRAS certification can effectively enhance consumers' confidence in their safety.
▶Self-affirmed GRAS (GRAS Self-Declaration):
The safety of the substance is recognized by a qualified panel of experts. This type of certification does not involve submitting a notification to the FDA and is generally not publicly disclosed. A substance can be sold in the United States through self-affirmed GRAS, but it has relatively lower authority and recognition.
▶FDA Notified GRAS (FDA GRAS Certification):
Notifications must be submitted to the FDA. After official review and approval by the FDA, the substance is included in the GRAS list and can be verified on the FDA’s official website. This type of GRAS is more authoritative and widely recognized.
Whether it is a self-affirmed GRAS status or FDA GRAS certification, a specific process must be followed, which includes steps such as preparing documentation, submitting the application, and undergoing evaluation and review. The detailed process is as follows:
▶ Documentation Preparation：Companys need to prepare a full English-language GRAS evaluation package, which should include basic information about the substance, intended use and usage levels, production processes, quality specifications and relevant analysis reports, food limitations, historical use in consumption, and safety assessments, etc.
▶ Submission of Application：Company need to submit the GRAS certification application and related materials to the FDA or a third-party organization as required.
▶ Initial Review：The submitted documents undergo preliminary review and analysis to confirm their completeness and compliance.
▶ Data Gap Analysis：Identifying all the information gaps and conducting a comprehensive literature search for publicly available data to find the most suitable solutions to address these gaps.
▶ GRAS Dossier Preparation：Organize and refine the GRAS evaluation materials to create a complete dossier.
▶ Expert/FDA Review：For a self-affirmed GRAS status, a third-party organization convenes an expert panel to review the GRAS dossier. For FDA GRAS certification, a GRAS notification application is submitted to the FDA for evaluation by FDA experts.
▶ Review Conclusion：Based on the review, the experts or FDA will provide a conclusion. If the conclusion is "no objections" or "no questions," the substance will be recognized as GRAS.
The timeline and costs for GRAS certification vary depending on factors such as product type, the preparation of necessary documentation, and whether additional testing is required. Generally, the self-affirmed GRAS process is expected to take around 6-9 months (excluding any testing or trial time), while the FDA GRAS certification process typically takes 1.5-2 years (also excluding the time required for any tests). In terms of costs, the total expenses for the certification process, including consulting fees and laboratory fees (if applicable), are estimated to range from tens of thousands to several hundred thousand USD.
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