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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION 21 CFR PARTS 182 AND 184 [DOCKET NO. 77N02321 GELATIN; TENTATIVE AFFIRMATION OF GRAS STATUS AS A DIRECT HUMAN FOOD INGREDIENT AGENCY:Food and Drug Administration,ACTION:TentativefinalHHS.rule.SUMMARY: The Food and Drug Administration affirmingthatgelatinuse as a direct ingredientps QW a+$ 0 rishuman foodconductedby theDATES:WrittencommentspublicationinADDRESSES:SubmitParklawnthe(HFA3051, Dr

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How to fill out 21 cfr parts 182

01

Identify the specific substances or materials you need to evaluate under 21 CFR Part 182.

02

Gather relevant data and information regarding the safety and suitability of these substances for their intended use.

03

Consult the guidelines laid out in 21 CFR Part 182 which outlines the criteria for substances generally recognized as safe (GRAS).

04

Prepare documentation that demonstrates the safety of the substances based on scientific evidence, including toxicology studies and historical usage.

05

Submit the required information to the FDA, ensuring that all data is accurate, thorough, and appropriately formatted.

06

Follow up with the FDA for any queries or additional information they may request during their review process.

Who needs 21 cfr parts 182?

01

Food manufacturers who utilize substances in food products that fall under GRAS.

02

Companies conducting research or production involving food additives that require regulatory compliance.

03

Regulatory affairs professionals ensuring that products align with federal standards for food safety.

04

Businesses involved in the import and export of food products that must comply with FDA regulations.

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What is 21 cfr parts 182?

21 CFR Part 182 pertains to substances affirmed as Generally Recognized as Safe (GRAS) for direct addition to food. These substances usually have a long history of safe use.

Who is required to file 21 cfr parts 182?

Individuals or companies who wish to use substances designated as GRAS in food products are required to file under 21 CFR Part 182.

How to fill out 21 cfr parts 182?

To fill out 21 CFR Part 182, submit a petition to the FDA that includes evidence of safety, intended uses, and compliance with regulatory standards.

What is the purpose of 21 cfr parts 182?

The purpose of 21 CFR Part 182 is to ensure that certain food substances are recognized as safe, allowing food manufacturers to use them without premarket approval.

What information must be reported on 21 cfr parts 182?

The information reported must include the identity of the substance, intended use, safety data, and any relevant studies supporting the GRAS status.

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