August 21, 2018

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Does FDA Clear Food Packaging Materials?

Question 

Is it possible to obtain a FCM approval from FDA for food packaging products (e.g., peelable lidding, MAP film for produce, etc.)? And, would an FCM approval cut down on the endless requirements for specific or GRAS compliance statements?

Answer 

The answer to your first question is “yes,” it is possible to verify FDA compliance for a food packaging product. Note, however, that FDA does not “approve” food-contact substances or finished food-contact materials (and, in fact, objects to that terminology); rather, FDA “clears” food-contact substances, and cleared food-contact substances may then be blended or assembled into compliant food packaging products.  The most common way to bring about an FDA clearance for a new food-contact substance (FCS) is to submit a Food Contact Notification (FCN) to FDA.  A similar type of submission may be used to establish compliance of a finished packaging material – this is called a Notification for a Food-Contact Substance Formulation (NFCSF). For FDA to accept an NFCSF, however, all components of that formulation must either be cleared already for their intended use (under an effective FCN, for example) or be subject to an exemption from the need for a specific clearance (e.g., a prior sanctioned substance). To submit an NFCSF, it is necessary to include a completed FDA Form No. 3470 and documentation that establishes that each component of the formulation may be marketed legally for its intended use (see Title 21 Code of Federal Regulations (C.F.R.) § 170.106).

FDA does not maintain a list of effective NFCSFs on its website in the way that the Agency maintains a list of effective FCN clearances (see here).  Therefore, the answer to your second question is likely to be “no” because you would need to document the clearance for each of the individual components of a food packaging product order to submit an NFSCF, and customers would likely continue to ask you for confirmation as to the compliance status of your packaging product even if it were the subject of an effective NFSCF given that the NFSCF clearance is not posted on FDA’s website.  For these reasons, very few NFCSFs have been filed with FDA since the start of the program in 2000.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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