Get the free GRAS Notice 853, Lysozyme produced by Trichoderma reesei. Lysozyme produced by Trich...

GAS Notice (GRN) No. 853 https://www.fda.gov/food/generallyrecognizedsafegras/grasnoticeinventory. Form Approved: 0 MB No. 09100342; Expiration Date: 02/29/2016 (See last page for 0 MB Statement)FDA

How to fill out gras notice 853 lysozyme

How to fill out gras notice 853 lysozyme

1. To fill out Gras Notice 853 Lysozyme, follow these steps:
2. Start by gathering all the necessary information and documents required for the notice.
3. Begin by providing the basic details such as the name of the applicant or company submitting the notice.
4. Clearly state the purpose of the application and the specific use of Lysozyme.
5. Provide a detailed description of the product containing Lysozyme and its intended use.
6. Include information on the manufacturing process, including any modifications or changes made during production.
7. Provide information on the safety evaluation of Lysozyme, including toxicological data and any relevant studies.
8. Include any information on the history of use, including any previous safety assessments or regulatory approvals.
9. Describe any known or potential risks associated with the use of Lysozyme and provide mitigation strategies if applicable.
10. Provide any additional supporting documentation or scientific studies that demonstrate the safety of Lysozyme.
11. Review and double-check all the information provided before submitting the Gras Notice to ensure accuracy and completeness.

Who needs gras notice 853 lysozyme?

1. Gras Notice 853 Lysozyme may be needed by manufacturers or companies involved in the production or use of Lysozyme-containing products.
2. This notice is typically required for those who intend to market or sell their products containing Lysozyme in the United States.
3. It helps to ensure regulatory compliance and demonstrate the safety of the ingredient to the Food and Drug Administration (FDA) and other relevant authorities.

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What is gras notice 853 lysozyme?

GRAS Notice 853 for lysozyme refers to a submission made to the FDA stating that lysozyme, an enzyme found in various bodily fluids, is generally recognized as safe (GRAS) for its intended use in food products.

Who is required to file gras notice 853 lysozyme?

Industries or companies that intend to use lysozyme as a food additive or ingredient are required to file GRAS Notice 853 lysozyme with the FDA.

How to fill out gras notice 853 lysozyme?

To fill out GRAS Notice 853, one must provide detailed information about the identity, safety, and intended use of lysozyme, including scientific data, proposed dosage, and a rationale for GRAS status.

What is the purpose of gras notice 853 lysozyme?

The purpose of GRAS Notice 853 for lysozyme is to inform the FDA that the substance is considered safe for its intended use, thereby facilitating its approval and use in food products.

What information must be reported on gras notice 853 lysozyme?

Information that must be reported includes the identity of lysozyme, its source, intended use in food products, safety data, and evidence supporting its GRAS status.