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None of these expected activities related to a draft version of the revised Form 3480 ever materialized. Our first sighting on FDA s website was in -3- February 2006. Recently FDA issued a revised version of Form 3480. The purpose of this report is to provide our comments on the revised version of the form and on the FCN program generally. Nonetheless FDA has now revised Form 3480 as is often the case with revisions FDA made many improvements but also introduced new aspects of the form that mak ...

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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.

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