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GAS Notice (GRN) No. 922 https://www.fda.gov/food/generallyrecognizedsafegras/grasnoticeinventoryMarch 19, 2020 Rachel Morissette, Ph.D. Regulatory Review Scientist Center for Food Safety and Applied

How to fill out gras notice no 922

How to fill out gras notice no 922

1. To fill out GRAS Notice No. 922, follow these steps:
2. Start by providing the basic information such as your name, contact details, and the name of your company or organization.
3. Clearly state the purpose of your notice and the specific substance you are seeking GRAS status for.
4. Include a detailed description of the substance, including its source, composition, and intended use.
5. Provide any relevant information regarding the history of use or consumption of the substance, including its safety data.
6. If available, include scientific studies, research articles, or other supporting evidence that demonstrates the safety of the substance.
7. Clearly outline any specifications or restrictions related to the substance, including its recommended dosage, maximum safe levels, or any special handling requirements.
8. Include a summary of any adverse effects or potential risks associated with the substance, along with any proposed mitigating measures.
9. Finally, sign and date the notice, and submit it to the appropriate regulatory agency or authority.
10. Note: It is advisable to consult with a legal expert or regulatory professional before submitting your GRAS Notice to ensure compliance with all relevant regulations and requirements.

Who needs gras notice no 922?

1. GRAS Notice No. 922 is needed by individuals, companies, or organizations that want to establish the safety of a substance and obtain GRAS (Generally Recognized as Safe) status for it.
2. This notice is often required by regulatory agencies or authorities to evaluate the safety of a substance before it can be used in food, dietary supplements, or other related products.
3. Individuals or companies in the food and beverage industry, as well as researchers or manufacturers of dietary supplements, may need to fill out GRAS Notice No. 922 to gain approval and ensure the safety of their products.
4. It is important to note that the specific requirements for GRAS notice may vary depending on the jurisdiction and regulatory framework in which it is being submitted. Therefore, it is advisable to consult the relevant regulatory authorities or seek legal advice to determine if GRAS Notice No. 922 is necessary for your particular situation.

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What is gras notice no 922?

Gras notice no 922 is a regulatory document that must be submitted to describe the safety and efficacy of a substance intended for food use.

Who is required to file gras notice no 922?

Any entity or individual who intends to market a substance claiming GRAS (Generally Recognized As Safe) status for food use is required to file gras notice no 922.

How to fill out gras notice no 922?

To fill out gras notice no 922, one must complete the required sections detailing the identity of the substance, its use, safety data, and relevant supporting information as per the guidelines provided by the FDA.

What is the purpose of gras notice no 922?

The purpose of gras notice no 922 is to inform the FDA about the intent to market a substance that is considered safe for consumption, ensuring regulatory compliance and consumer safety.

What information must be reported on gras notice no 922?

Information that must be reported on gras notice no 922 includes the identity of the substance, its intended use, safety assessments, manufacturing processes, and any supporting scientific evidence.