March 25, 2019

March 25, 2019

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March 22, 2019

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What are FDA regulations concerning UV coatings?

Question 

Can a UV coating be used on the outside of a paper cup if properly cured?

Answer 

A UV coating, as well and any coating, on the outside of a paper cup may need to be cleared for use with food and beverages. It will depend upon whether components in the coating are expected to migrate through the cup into the food. In addition, the potential for mouth contact with the coating on the outside of the cup should be considered. Since coatings tend the be complex chemical substances, in many cases, FDA clears the precursor materials rather than the finished substance. As a result, an evaluation of whether a coating on a particular substrate is compliant often must be conducted on a case-by-case basis, taking into account the full composition of the coating and its intended conditions of use.

With respect to UV technology, FDA specifically addressed its use for direct food contact under the Food Contact Notification (FCN) program when, in 2008, FCN 772 became effective. FCN 772 clears the use of certain UV or electronic beam formulations to be used as coatings or components of coatings on polymeric substrates, paper and paperboard, metal substrates, or as a component in adhesives, when certain specification (i.e., migration limits) are met. Since the notification was submitted to FDA by the RadTech Food Packaging Alliance and since FCNs are proprietary to the organization that submits them, only alliance members and their customers may use the materials and formulations cleared by FCN 772. Importantly, any component of the coating not included in FCN 772 must have a suitable FDA status for the proposed use. There are a number of substances that are authorized for various food contact coating applications under FDA’s indirect additive regulations, such as Title 21 of the Code of Federal Regulations (C.F.R.) § 176.170 that authorizes certain substances for use in coatings for paper and paperboard.

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PackagingLaw.com is the premier online resource for the global packaging industry. It provides a wide range of information on laws and regulations—both in the U.S. and other countries throughout the world—that affect packages and packaging materials. PackagingLaw.com features news articles on current issues affecting the packaging industry, in-depth features, an Ask an Attorney section, links to packaging industry and government websites, and detailed information on the U.S. Food and Drug Administration (FDA) Food Contact Notification system.

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