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GAS Notice (GRN) No. 905 https://www.fda.gov/food/generallyrecognizedsafegras/grasnoticeinventoryJHeimbach LLC JAN 2 S 2020January 21, 2020OFFlCE OF FOOD Additive SAFETY Susan J. Carlson, Ph.D., Director Division
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To fill out GRAS Notice 905 Bacillus, follow these steps:
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Begin by entering the basic information at the top of the notice form, including the submitter's name, address, and contact information.
03
Provide a concise statement of the intended use of Bacillus in food, including the specific food categories or products.
04
Describe the source and production methods of the Bacillus strain, including any genetically modified organisms (GMOs) involved.
05
Include a detailed discussion of the identity and characteristics of the Bacillus strain, highlighting any unique features or properties.
06
Present relevant data and studies on the safety of Bacillus for its intended use, including information on toxicology, allergenicity, and antimicrobial resistance.
07
Include any additional information or supporting documents that may be necessary to assess the safety of Bacillus.
08
Provide a summary of the notifications or approvals received from other regulatory agencies, if applicable.
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Include a comprehensive list of references cited throughout the notice.
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Finally, sign and date the notice form, and submit it to the appropriate regulatory authority.
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Who needs gras notice 905 bacillus?

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GRAS Notice 905 Bacillus may be needed by manufacturers or suppliers of Bacillus as a food ingredient.
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These entities may need to submit the notice to the regulatory authority to demonstrate the safety of Bacillus for its intended use in food products.
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It is also important for companies seeking to inform the regulatory authority about any unique features or characteristics of their Bacillus strain.
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Ultimately, anyone involved in the production or use of Bacillus in food may need GRAS Notice 905 Bacillus to ensure compliance with regulatory requirements.
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GRAS Notice 905 Bacillus refers to a specific notification submitted to the FDA regarding a strain of Bacillus that is considered Generally Recognized As Safe (GRAS) for its intended use in food or feed products.
Any company or entity that intends to use a Bacillus strain in food or feed products and believes it meets the criteria for GRAS status is required to file GRAS Notice 905.
To fill out GRAS Notice 905, one must provide detailed information about the Bacillus strain, its intended use, safety assessments, and any supporting documents or scientific data that demonstrate its safety.
The purpose of GRAS Notice 905 is to inform the FDA about the use of a specific Bacillus strain in food products, and to affirm its safety for consumption in accordance with the GRAS criteria.
The information that must be reported includes the identity of the Bacillus strain, its production method, proposed uses, safety data, and any relevant research or studies supporting its GRAS status.
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