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GAS Notice (GRN) No. 897 https://www.fda.gov/food/generallyrecognizedsafegras/grasnoticeinventoryJHeimbach LLC November 21, 2019, Susan J. Carlson, Ph.D., Director Division of Biotechnology and GAS

How to fill out gras notice 897 2-o-fucosyllactose

How to fill out gras notice 897 2-o-fucosyllactose

1. To fill out GRAS Notice 897 2-o-fucosyllactose, follow these steps:
2. Begin by gathering all the necessary information and documentation related to your product, including safety studies, manufacturing process details, and supporting data.
3. Access the online portal provided by the regulatory authority responsible for GRAS notifications.
4. Create an account or log in to your existing account on the portal.
5. Navigate to the section for submitting a new GRAS notice.
6. Fill in the required fields accurately, providing information about the product's identity, intended use, manufacturing process, and safety studies.
7. Attach all relevant supporting documents and studies as per the portal's guidelines.
8. Review the completed form and ensure all information is accurate and complete.
9. Submit the GRAS Notice 897 2-o-fucosyllactose through the portal.
10. Pay any applicable fees as per the regulatory authority's instructions.
11. Await confirmation and further communication from the regulatory authority regarding the status of your GRAS notice.

Who needs gras notice 897 2-o-fucosyllactose?

1. GRAS Notice 897 2-o-fucosyllactose may be needed by manufacturers or suppliers of food or food ingredients containing or derived from 2-o-fucosyllactose. It is required for those who intend to demonstrate that 2-o-fucosyllactose is generally recognized as safe (GRAS) for its intended use in food products.
2. This notice is important for individuals or companies aiming to market or use 2-o-fucosyllactose as an ingredient in food and wishing to provide evidence supporting its safety to the regulatory authorities.

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What is gras notice 897 2-o-fucosyllactose?

GRAS Notice 897 pertains to the substance 2-o-fucosyllactose, which is recognized as Generally Recognized as Safe (GRAS) for its intended use in food and beverages.

Who is required to file gras notice 897 2-o-fucosyllactose?

Manufacturers or producers who intend to use 2-o-fucosyllactose in food and beverages are required to file GRAS Notice 897.

How to fill out gras notice 897 2-o-fucosyllactose?

To fill out GRAS Notice 897, you must provide detailed information about the substance, including its manufacturing process, safety data, and intended uses, following the specific guidelines provided by the FDA.

What is the purpose of gras notice 897 2-o-fucosyllactose?

The purpose of GRAS Notice 897 is to inform the FDA about the safety and intended use of 2-o-fucosyllactose, ensuring that it meets the safety standards set for food substances.

What information must be reported on gras notice 897 2-o-fucosyllactose?

The information that must be reported includes the identity of the substance, its manufacturing process, levels of use, safety assessments, and relevant scientific literature.