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GAS Notice (GRN) No. 825 https://www.fda.gov/food/generallyrecognizedsafegras/grasnoticeinventoryMo1gan Lewis Gary L. Ringling Senior Counsel +1.202 .739.5610 gary.yingling@morganlewis.comNovember

How to fill out gras notice 825 beta-galactosidase

How to fill out gras notice 825 beta-galactosidase

1. Start by reviewing the instructions and requirements provided by the regulatory authority for filling out the GRAS Notice 825 for beta-galactosidase.
2. Gather all the necessary information and supporting documents required for the notice, such as safety data, manufacturing process description, intended use, and any scientific studies or research findings.
3. Begin filling out the notice by providing the necessary contact information, including the name, address, and contact details of the notifier.
4. Clearly state the identity of the substance, in this case, beta-galactosidase, and provide its chemical, physical, and biological characteristics.
5. Describe the manufacturing process of beta-galactosidase, including the raw materials used, processing methods, and quality control measures.
6. Detail the intended use and purpose of beta-galactosidase, including its proposed concentration or dosage, target population, and any specific applications or functions.
7. Include a comprehensive safety assessment of beta-galactosidase, considering potential hazards, toxicological data, allergenicity, and any potential adverse effects or risks associated with its use.
8. Provide any additional supporting data or literature references that demonstrate the safety and efficacy of beta-galactosidase.
9. Review the filled-out notice for accuracy, completeness, and clarity, ensuring that all required sections and information have been adequately addressed.
10. Submit the completed GRAS Notice 825 for beta-galactosidase to the appropriate regulatory authority following the specified submission guidelines.

Who needs gras notice 825 beta-galactosidase?

1. Food manufacturers or producers who intend to use beta-galactosidase as an ingredient in their products may need to file a GRAS Notice 825. This requirement may vary depending on the regulatory jurisdiction and specific product category.
2. It is recommended to consult the local regulatory authority or seek professional advice to determine if the specific use of beta-galactosidase requires a GRAS Notice 825.

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What is gras notice 825 beta-galactosidase?

GRAS notice 825 beta-galactosidase refers to a Generally Recognized as Safe (GRAS) notice submission for the enzyme beta-galactosidase, which is used in food processing to break down lactose.

Who is required to file gras notice 825 beta-galactosidase?

Any entity that intends to use beta-galactosidase in food products and seeks to establish its safety can file GRAS notice 825.

How to fill out gras notice 825 beta-galactosidase?

To fill out GRAS notice 825, you need to provide detailed information on the identity and source of beta-galactosidase, its intended use levels, safety data, and relevant scientific literature.

What is the purpose of gras notice 825 beta-galactosidase?

The purpose of GRAS notice 825 is to inform the FDA about the safety of beta-galactosidase for its intended use in food products.

What information must be reported on gras notice 825 beta-galactosidase?

The information required includes the identity of the substance, intended use, production method, safety assessments, and any data supporting the GRAS conclusion.