How are Adhesives That are Separated from Food By a Functional Barrier Regulated?
Do all the components of an adhesive for food packaging (cardboard boxes) have to be in the list of cleared substances found in 21 C.F.R. 175.105, or can the manufacturer certify that the whole adhesive meets FDA's requirements found in 175.105 when the adhesive is separated from the food by a functional barrier, and is manufactured according to GMP practice?
The U.S. Food and Drug Administration (FDA) clears the use of various substances that may be used in adhesive formulations intended for the packaging, transporting, or holding of food under Title 21, Code of Federal Regulations (C.F.R.) § 175.105 on Adhesives. This section specifies that manufacturers of finished food packaging must ensure that adhesives either are separated from food by a functional barrier or meet specified conditions that limit potential migration. Consequently, in many cases, adhesive formulations may contain substances that are not explicitly listed in Section 175.105 but may still be used as intended, provided that the adhesive is separated from food by a functional barrier in any finished food packaging or is used in accordance with GMP as prescribed by Section 175.105.
With respect to assurances for customers, a common form of assurance is a simple letter from the supplier to its customer advising that the packaging material in question is in compliance with applicable regulations and relevant quality specifications. An assurance letter can specify the intended uses covered by the assurance (i.e., use with a functional barrier). Or, a supplier can cite an applicable regulation, which alerts customers to limitations specified in the regulations. For more information on different types of assurance that a food packaging manufacturer can provide to customers, please see a PackagingLaw.com article on this topic.