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GAS Notice (GRN) No. 1014 with amendments https://www.fda.gov/food/generallyrecognizedsafegras/grasnoticeinventorySCGSpherix Consulting Group June 4, 2021, Center for Food Safety and Applied !\'Nutrition
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To fill out GRAS notice 1014 2-fucosyllactose, follow these steps:
02
Begin by providing general information about the substance, such as its chemical name and structure.
03
Provide information about the source of the substance and the method of production.
04
Include data on the intended use of 2-fucosyllactose and the recommended maximum level of use.
05
Describe the safety studies conducted on the substance, including toxicological and allergenicity data.
06
Provide information on the anticipated dietary exposure to 2-fucosyllactose.
07
Include a summary of the overall conclusion regarding the safety of the substance for its intended use.
08
Submit the completed GRAS notice 1014 2-fucosyllactose to the appropriate regulatory authorities.
09
Follow up with any additional information or clarifications requested by the authorities.

Who needs gras notice 1014 2-fucosyllactose?

01
GRAS notice 1014 2-fucosyllactose is required by manufacturers or producers of food and food ingredients that intend to market or use 2-fucosyllactose as a food ingredient.
02
It is necessary for those who want to establish the substance as Generally Recognized as Safe (GRAS) for its intended use before it can be legally added to food products.
03
The notice provides the scientific data and safety assessment required to demonstrate the safety of 2-fucosyllactose as a food ingredient.
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Gras notice 1014 2-fucosyllactose is a notification required by the FDA for the addition of 2-fucosyllactose to food products.
Any company or individual planning to add 2-fucosyllactose to food products and distribute them in the US market.
The gras notice must be completed online through the FDA's Electronic Submission Gateway (ESG). Detailed instructions can be found on the FDA's website.
The purpose of the gras notice is to provide the FDA with information about the safety and intended use of 2-fucosyllactose in food products.
The report must include information on the source of 2-fucosyllactose, its intended use, manufacturing process, safety data, and any relevant scientific studies.
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