Knowledge Articles
01 June 2023

US Food Contact Products regulation

By Trivium Communications
The scope of US food safety law

Trivium Packaging products that are used for food packaging may be subject to the main food safety law of the US, the Federal Food, Drug, and Cosmetics Act (FFDCA). Under this law, the US Food and Drug Administration (FDA) regulates food and food additives, including materials that are intended to be used in contact with food such as food packaging. The definitions of items regulated by the FDA are broad enough to encompass some Trivium Packaging products and materials.

Definition and approval process of a food contact substance (FCS)

A food contact substance (FCS) is defined as any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food, if use of the substance is not intended to have any technical effect in the food. An FCS may be considered an indirect additive, which needs to be approved by the FDA. The approval may occur through listing or meeting the requirements in 21 Code of Federal Regulations Parts 173-186. These regulations contain separate sections for adhesive and coatings; paper and paperboard; polymers; and adjuvants, production aids, and sanitizers. In some cases, for additives not already approved or that do not meet the requirements of these regulations, it may be necessary to submit a food contact notification to FDA before manufacturing or using an FCS.

Exemptions to FDA review for food packaging substances

A food packaging substance may be used without prior FDA review when there is a sound basis for concluding that it is not a food additive because it is not reasonably expected to become a component of food under the conditions of its intended use. This is a determination that a company can make when there is evidence based on extraction studies and/or calculations that the substances will not migrate into the food. There are a number of other exemptions that are outlined in the regulations and the FDA guidance.

Compliance with the US Food Contact Products regulation

Trivium Packaging’s product compliance team includes experts on the requirements that apply to the products we sell for food packaging applications. This team also helps our product development team with the aim that the materials we use in products intended for food contact comply with the requirements of the U.S. FDA.  Our product compliance team is available to support our customers with food contact compliance data, including migration test results and other information on the suitability of our products for use with food. We provide food contact declarations as necessary and applicable.

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Trivium Packaging’s Product Stewardship and Sustainability team monitors the regulatory landscape continuously. The team maintains this article to enhance public knowledge on regulations related to rigid metal packaging solutions. Our goal is to keep this information timely and accurate. If errors are brought to our attention, we will try to correct them. However, Trivium Packaging accepts no responsibility or liability whatsoever with regard to the accuracy, currency or completeness of the information in this article.