Get the free GRAS NOTICE 837, Hydroxytyrosol

GAS Notice (GRN) No. 837 https://www.fda.gov/food/generallyrecognizedsafegras/grasnoticeinventory! RI(C ':# ! Nova Mantis Nova UCD Bellied Innovation Park Dublin 4 Ireland D04 V1W8 Tel:+353 85 7227580JAN

How to fill out gras notice 837 hydroxytyrosol

How to fill out gras notice 837 hydroxytyrosol

1. To fill out GRAS notice 837 for hydroxytyrosol, follow these steps:
2. Begin by gathering all the necessary information and documentation related to hydroxytyrosol, including scientific research, safety studies, and toxicology data.
3. Write a detailed introduction to the notice, explaining the purpose and scope of the submission.
4. Provide a thorough description of hydroxytyrosol, including its properties, production process, and intended uses.
5. Include information about the estimated daily intake of hydroxytyrosol and any potential exposure from various sources.
6. Present a comprehensive review of the available scientific literature supporting the safety and efficacy of hydroxytyrosol.
7. Detail any known or potential adverse effects associated with the use of hydroxytyrosol.
8. Include a section on manufacturing controls, quality assurance, and specifications for hydroxytyrosol.
9. Provide information about the intended conditions of use, including recommended dosage, target population, and any labeling instructions.
10. Discuss any potential allergenicity or sensitization risks associated with hydroxytyrosol.
11. Conclude the notice by summarizing the overall safety assessment and providing a rationale for the conclusion.
12. Attach all supporting documents, studies, and data to the notice.
13. Submit the completed GRAS notice 837 for hydroxytyrosol to the appropriate regulatory authority.
14. Note: It is essential to ensure that all information provided is accurate, scientifically valid, and up-to-date.

Who needs gras notice 837 hydroxytyrosol?

1. Anyone involved in the production, distribution, or sale of hydroxytyrosol as a food ingredient or dietary supplement may need GRAS notice 837.
2. This includes manufacturers, importers, formulators, and marketers who want to demonstrate the safety of hydroxytyrosol for human consumption.
3. Regulatory authorities responsible for evaluating the safety of food ingredients and additives may also require or request GRAS notices for hydroxytyrosol.
4. It is advisable to consult with legal and regulatory experts to determine the specific requirements and obligations related to GRAS notices for hydroxytyrosol in your jurisdiction.

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What is gras notice 837 hydroxytyrosol?

GRAS Notice 837 refers to a submission made to the FDA regarding hydroxytyrosol, a phenolic compound found in olive oil, which is claimed to be Generally Recognized as Safe (GRAS) for use in food.

Who is required to file gras notice 837 hydroxytyrosol?

Any manufacturer or supplier intending to market hydroxytyrosol as a food ingredient may be required to file GRAS Notice 837 with the FDA.

How to fill out gras notice 837 hydroxytyrosol?

To fill out GRAS Notice 837, you need to provide detailed information about the substance, its proposed uses, safety evidence, and any scientific data supporting the GRAS status.

What is the purpose of gras notice 837 hydroxytyrosol?

The purpose of GRAS Notice 837 is to inform the FDA about the safety of hydroxytyrosol as a food ingredient and to provide assurance that it is safe for use in food products.

What information must be reported on gras notice 837 hydroxytyrosol?

The report must include the identity of the substance, its intended uses, the basis for its GRAS designation, and relevant safety and toxicological data.