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FDA Regulation of Adhesives in Food Packaging

Posted By ASC, Tuesday, June 23, 2015

The U.S. Food and Drug Administration (FDA) regulates the use of adhesives in food labeling and packaging as indirect food additives or food contact substances. While food additives require premarket clearance, the subset of food contact substances that do not migrate are not considered food additives. As a result, that subset of food contact substances does not require premarket clearance.  When a food packaging material, such as an adhesive, does qualify as a food additive, it is within the category of “indirect food additives.” The FDA regulates adhesive used in packaging and transport of food under Title 21 of the Code of Federal Regulations (C.F.R.) Section 175.105. Manufacturers may use any compound listed Section 175.105(c), subject to specific regulations listed for that compound, as well as physical restrictions that the adhesive is separated from the food by a functional barrier, and the quantity of adhesive is within the limits of Good Manufacturing Practices (GMPs). The FDA provides further clearance for adhesives in multilayer laminates in 21 C.F.R. Sections 177.1395 (laminates used between 120 °F and 250 °F) and 177.1390 (laminates used at or above 250 °F).  Food contact adhesives not listed within food additive regulation may still be cleared by the FDA through a threshold of regulation (TOR) exemption or a food contact notification (FCN).

 

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