The labeling requirements for an antimicrobial substance used as part of a food packaging material to extend shelf-life depend on whether or not the antimicrobial substance is intended to have a technical effect on the packaging material only, or on both the food and the packaging material. Generally speaking, an antimicrobial substance intended to have a technical effect exclusively on the packaging material is not required to be included as part of a food ingredient statement. If the antimicrobial substance however, is used in packaging material with the intention of the antimicrobial substance having a direct technical effect on the food (i.e., killing or retarding the growth of spoilage organisms on the food, or otherwise acting as a preservative), then such use of the antimicrobial substance may necessitate inclusion in the food label ingredient statement.

An antimicrobial substance used as part of a food packaging material to extend shelf life through a technical effect on the packaging only, is exempted from the food labeling requirements of section 403(i)(2) of the Federal Food Drug and Cosmetic Act (the Act). In this circumstance, the antimicrobial substance would be considered an incidental indirect additive likely to be present in food at insignificant levels with no technical or functional effect on the food. Therefore, under 21 C.F.R. §101.100(a)(3), the antimicrobial substance packaging additive would not need to be listed in the food label ingredient statement. For example, ethanol has demonstrated efficacy in increasing the mold-free shelf life of baked goods when sprayed onto product surfaces prior to packaging. As long as the packaging additive is protecting the packaging from growing mold, which in turn discourages the growth of mold in or on food, then the packaging additive is regulated as an indirect additive not subject to food labeling requirements.

An antimicrobial substance used in a food packaging material that is intended to have a direct technical and on-going effect on the food itself, however, may be subject to labeling requirements. In this case the antimicrobial would be considered a direct food additive. Direct food additives are not subject to the exemptions from food labeling requirements under 21 C.F.R. §101.100 and therefore must be included as part of the food label ingredient statement. For example, an antimicrobial substance included on food packaging with the intention of the antimicrobial substance transferring to the surface of the food in order to deter bacteria growth and formation in the food itself, would be considered a direct additive and would need to be included as an ingredient in the food as a preservative.

Please note that these antimicrobial products may be subject to other regulatory requirements as well.