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GAS Notice (GRN) No. 817 https://www.fda.gov/food/generallyrecognizedsafegras/grasnoticeinventoryABEnzymesAB Enzymes GmbH Feldbergstrasse 78, D64293 Darmstadtium 18, 2018 RE: GAS Notification Exemption
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How to fill out gras notice 817 serine
How to fill out gras notice 817 serine
01
To fill out GRAS notice 817 Serine, follow these steps:
02
Begin by providing general information about the notifier, including the name and contact details.
03
Specify the subject of the notice, which in this case is 'Serine' as per GRAS notice 817.
04
Provide a detailed description of the intended use of Serine and the specific food category it will be used in.
05
Include scientific data and evidence supporting the safety of Serine and its suitability for the intended use.
06
Describe the manufacturing process of the food ingredient containing Serine.
07
Discuss the estimated intake levels of Serine by the general population and any potential risks associated with its use.
08
Provide information on the history of use and consumption of Serine, including its use in other countries if applicable.
09
Include any relevant references, studies, or expert opinions that support the safety and suitability of Serine.
10
Attach any necessary documentation, such as toxicological studies or safety assessments.
11
Review the completed GRAS notice 817 Serine carefully for accuracy and completeness before submission.
Who needs gras notice 817 serine?
01
GRAS notice 817 Serine is needed by food manufacturers or companies that intend to use Serine as a food ingredient.
02
It is specifically applicable to those who want to establish the safety of Serine for its proposed use in specific food categories.
03
The notifier, usually a food manufacturer or distributor, is responsible for submitting the GRAS notice to the relevant regulatory authorities.
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What is gras notice 817 serine?
GRAS Notice 817 relates to a substance known as serine, which is considered Generally Recognized as Safe (GRAS) for use in food and dietary supplements.
Who is required to file gras notice 817 serine?
Manufacturers or suppliers of food or dietary ingredients that intend to market serine for consumption are typically required to file GRAS Notice 817.
How to fill out gras notice 817 serine?
To fill out GRAS Notice 817, you need to provide information including the identity of the substance, the intended uses, the safety data, and a summary of the basis for GRAS status.
What is the purpose of gras notice 817 serine?
The purpose of GRAS Notice 817 is to inform the FDA about the intention to market serine as a GRAS substance and to assure compliance with safety standards.
What information must be reported on gras notice 817 serine?
Information that must be reported includes the identity and composition of serine, intended uses, the safety assessment, and any relevant literature supporting the safety of the substance.
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