Us fda form 3480-2025

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The document is a Technical Advisor's Report by Dr. Lester Borodinsky to the Food, Drug, and Cosmetic Packaging Materials Committee, discussing the FDA's revision of Form 3480 used in the Food Contact Notification (FCN) program. It outlines the history and current status of the FCN program, highlights improvements and challenges in the revised Form 3480, and provides specific comments on its sections. The report emphasizes the need for clearer instructions and better organization within the form to facilitate its use. Additionally, it touches on finalized environmental assessment guidelines related to food-contact substances.

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Click ‘Get Form’ to open the US FDA Form 3480 in the editor.
Begin with Part I - General Information. Fill in your contact details and the name of the food-contact substance (FCS). Ensure all fields are completed accurately.
Move to Part II - Chemistry Information. Here, you will need to provide detailed information about the ingredients used in your FCS. Use the provided tables for clarity.
In Part III - Safety Narrative, summarize safety data related to your FCS. This section is crucial for demonstrating compliance with safety standards.
Proceed to Part IV - Environmental Information. Indicate whether an Environmental Assessment is required and provide necessary details.
Complete Parts V and VI, which include Certification and List of Attachments respectively. Make sure all required documents are attached.
Review all sections for completeness and accuracy before submitting your form through our platform.

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What is a food contact notification?

FCSs are evaluated primarily through the food contact notification (FCN) program. Federal law requires companies who wish to use a food contact substance to submit Food Contact Substance Notifications (FCNs) to FDA prior to marketing the product. The FDA has a mandated 120-day time-period to review that submission.

Does plastic have to be food grade?

Food grade plastic is plastic material deemed safe for use with foods. Plastic must meet strict requirements in order to be considered food safe, and is regulated by higher standards than plastic used for other purposes.

What is FDA food contact?

The amended FD&C Act (United States, 1998a) defined a food-contact substance as "any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food."

Which of the following packaging material is FDA approved?

FDA-Compliant Plastics | Medical Device Plastic There is a long list of plastics approved for medical devices and medical device packaging. These include formulations of Nylon, Rulon 641, Polycarbonate, PEEK, and many more.

Can food be sold without being FDA approved?

Even when FDA approval is not required before a product is sold, the agency has legal regulatory authority to act when safety issues arise.

What is FDA food Grade?

Food grade means that the material is either safe for human consumption or it is okay to come into direct contact with food products.

How do you know if a product is food grade?

For something to be considered food grade, the material must be able to be cleaned effectively, and not allow any foreign particles to find their way into food. Generally, the surface should be smooth and free of any imperfections such as cracks, ridges or crevices, where bacteria could grow.

How do you know if a material is FDA approved?

Is there a Web site I can go to? To find out if a drug is approved by FDA, consumers can use two different Internet sites: Drugs@FDA lists most prescription and over-the-counter (OTC) drug products approved since 1939.

Us fda form 3480-2025

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