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Is GMP Certification Required?


Are packaging manufacturers required to be GMP (good manufacturing practices) certified?


In the U.S., there are no federal laws requiring food packaging manufacturers to be GMP certified, however, manufacturers of food-contact substances must comply with the GMP regulation for food packaging materials, “General Provisions applicable to indirect food additives,” found in Title 21 of the Code of Federal Regulations (C.F.R.) §174.5. This regulation requires that food-contact substances be suitably pure for their intended use and only be used in an amount necessary to achieve their function or purpose. For more information on these GMP requirements, see the article, Enduring the Safety of Food Contact Materials: GMPs and Beyond. With respect to packaging that comes into contact with dietary supplements, GMP requirements specify that the packaging must be safe and suitable for its intended use. In addition, the packaging must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement. (See 21 C.F.R. §111.70(d).)

While food or dietary supplement packaging manufacturers are not required to be GMP certified under federal law, individual clients may require certification.

© 2020 Keller and Heckman LLPNational Law Review, Volume IX, Number 343


About this Author 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. 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.