Get the free GRAS Notice (GRN) No. 700, Paracoccus carotinifaciens extract containing carotenoids...

GAS Notice (GRN) No. 700 https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/default.htmGRAS Notice for AstaxanthinRich Carotenoid Extracts from Para coccus carotinifaciensPrepared

How to fill out gras notice grn no

How to fill out gras notice grn no

1. To fill out a GRAS (Generally Recognized as Safe) Notice GRN No, follow these steps:
2. Begin by providing the contact information of the notifier, including their name, address, phone number, and email address.
3. Specify the identity of the substance or food ingredient being notified, including its chemical name, synonyms, and any common or usual names it is known by.
4. Give a detailed description of the intended use of the substance or food ingredient, including the proposed level of use and the specific food categories it will be used in.
5. Provide information about the safety of the substance, including relevant studies, toxicity data, and exposure estimates. This should include details on the substance's history of use in food.
6. Discuss any potential estimated dietary exposure to the substance or food ingredient, taking into account different population groups, such as infants, children, and adults.
7. Summarize the results of any published or unpublished safety studies conducted on the substance, including any observations of adverse effects.
8. Include any relevant information or data on the substance's chemical properties, manufacturing process, and specifications.
9. Provide a conclusion regarding the safety of the substance, supported by the available data and scientific evidence.
10. Finally, sign and date the GRAS Notice to certify its accuracy and completeness.
11. Note: It is advisable to consult the appropriate regulatory authorities or seek legal advice when filling out a GRAS Notice GRN No, as requirements may vary.

Who needs gras notice grn no?

1. GRAS Notice GRN No is needed by companies or individuals who want to provide scientific evidence that a substance or food ingredient meets the FDA's criteria for being considered Generally Recognized as Safe.
2. This can include manufacturers, importers, or distributors of food items who wish to use a new substance or ingredient in their products and want to ensure its safety.
3. Obtaining a GRN No helps demonstrate that the substance can be used without prior approval from the FDA, saving time and resources in the regulatory process.
4. It is important to note that not all substances or ingredients are eligible for GRAS status, and careful evaluation of the scientific evidence is necessary before making a GRAS notification.

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