Plastic Packaging Products From China

Regulation of food packaging is done on a much more generic basis than regulation of medical packaging. The primary concern with approval of plastic resins for food packaging is that the package does not adulterate the food in some way that could potentially be harmful to the consumer. Thus the main concern is migration of constituents from the plastic packaging material to the food or beverage with which it is in contact. In the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act, the U.S Congress gave the FDA jurisdiction over both direct and indirect food additives.

While one might not expect the Food, Drug, and Cosmetic Act to regulate medical devices, that act has, in fact, covered medical devices since 1938. That regulation became more stringent with the Medical Device Amendments of 1976, which brought to some medical devices the same premarket approval needed for drugs. The amount and type of regulation of medical devices depends on their classification. All medical devices intended for human use are classified by expert panel as ClassⅠ- General Controls, ClassⅡ- Special Controls, or Class Ⅲ – Premarket Approval. Devices in ClassⅠrequire truthful labeling, record keeping, and other fairly standard rules, including adherence to good manufacturing practices. Premarket notification is also required, meaning that the manufacturer must notify FDA of its intent to market the product, but need not wait for FDA approval. Class Ⅲ devices require the same general type of premarket approval as drugs, including approval of the packaging. The new device regulation has become more overtly a process control regulation, and specifies that the package is a component of the device.

There are a number of types of regulations that plastic packaging and the plastics packaging industries must meet, around the world. Most of these regulations are not directly aimed at plastics packaging, but rather are parts of more broad-based requirements relating to workplace safety, pollution prevention, product labeling, tamper evidence, and a variety of other concerns. Most of these are beyond the scope of this article. The regulations discussed in this chapter are those which limit the selection of a plastic type for a particular application, and/or limit the constitutes of a plastic resin, including additives, monomer residues, and other ingredients. Typically, these regulations depend on the use of the packaging, and are most stringent for pharmaceutical or other medical products, somewhat less so far foods, still less stringent for cosmetics, and much less so for most other types of products. Our discussion in this chapter will cover only the regulatory situation in the United States. With the increasing globalization of trade, it is, of course, important to be aware of regulations in other countries around the world.