Chapter 9 - The Impact of Global Regulations on Packaging

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The global success of a brand relies on the ability to create packaging and brand image within the right regulatory framework. The first element in a product packaging is to consider how it is defined; in some countries, a product might be a drug, a cosmetic, or a separate group entirely, depending on the perspective of the regulatory agency. The second key element is the ingredients—from a labeling perspective. The last key element is the packaging component itself—the bottle, tube, vial, carton, plastic sleeve, etc. Many innovative product packaging ideas, shapes, styles, and materials have been developed, however the packaging components must meet the regulatory issues. This chapter discusses the regulatory requirements applied to the basic primary and secondary packaging components in the United States and European Union (EU). The “Statement of Identity” (SOI) is a mandatory requirement in almost all cosmetics markets unless the product function is obvious from the presentation (the packaging component). The net quantity of contents (weight claim) labeled on primary and secondary packaging is one of the most highly regulated requirements. Warnings and instructions for use of products are required to be labeled when mandated by regulation or when deemed necessary for the safe use of the product by the consumer. Typically, prominent and conspicuous warning statements must appear on both the inner and outermost packaging. In most countries, the ingredient listing using INCI names must be placed only on the outermost packaging. The name and address of the manufacturer, packer, or distributor is required in all countries. In addition to these basic regulations, there will always be additional labeling regulations that must be satisfied, depending on the country or region in which the product is to be marketed.