GRAS Notice 000458 Xylooligosaccharides Fda Form

What is the GRAS Notice 000458 Xylooligosaccharides FDA

The GRAS Notice 000458 pertains to xylooligosaccharides, which are carbohydrates derived from plant sources. This notice is a submission to the FDA, indicating that xylooligosaccharides are Generally Recognized As Safe (GRAS) for use in food products. The GRAS designation allows manufacturers to use these substances without the need for pre-market approval, provided they can demonstrate safety based on scientific evidence and consensus among qualified experts.

How to use the GRAS Notice 000458 Xylooligosaccharides FDA

Using the GRAS Notice 000458 involves understanding its implications for food product formulation. Manufacturers can incorporate xylooligosaccharides into their products, such as dietary supplements and functional foods, as long as they comply with the specifications outlined in the notice. It is essential to ensure that the products meet safety standards and labeling requirements established by the FDA.

Steps to complete the GRAS Notice 000458 Xylooligosaccharides FDA

Completing the GRAS Notice involves several key steps:

• Gather scientific data supporting the safety of xylooligosaccharides.
• Prepare a comprehensive GRAS notice document that includes the identity, intended use, and safety data.
• Submit the notice to the FDA, including all required information and supporting documents.
• Await feedback from the FDA, which may involve answering questions or providing additional data.

Legal use of the GRAS Notice 000458 Xylooligosaccharides FDA

The legal use of the GRAS Notice is contingent upon adherence to FDA regulations. Manufacturers must ensure that their use of xylooligosaccharides aligns with the specifications outlined in the notice. This includes maintaining accurate records of safety assessments and being prepared to demonstrate compliance during inspections or audits.

Key elements of the GRAS Notice 000458 Xylooligosaccharides FDA

Key elements of the GRAS Notice include:

• The scientific basis for safety, including toxicological studies and historical use.
• A detailed description of the intended use and application in food products.
• Information on manufacturing processes and quality control measures.
• Labeling requirements to inform consumers about the ingredient's presence in food products.

Eligibility Criteria

Eligibility for using the GRAS Notice 000458 requires that the xylooligosaccharides meet specific criteria set by the FDA. This includes demonstrating that the substance is safe under the conditions of its intended use and that it has a history of safe consumption in food products. Manufacturers must also ensure that they have adequate scientific evidence to support their claims.

Application Process & Approval Time

The application process for the GRAS Notice involves submitting the notice to the FDA, which will review the documentation provided. The approval time can vary, but manufacturers should expect a response within 90 days. During this period, the FDA may request additional information or clarification to ensure that the safety and efficacy of xylooligosaccharides are well established.