Compendial Requirements for Plastic Packaging: A Global Comparison

Companies filing in more than one market quickly discover that compendial requirements for plastic packaging are not harmonized. This article compares the main frameworks and highlights what buyers should request from suppliers.

The Four Frameworks

United States — USP. USP <661.1> addresses plastic materials of construction, setting out requirements for material characterization, extractables assessment, and biological reactivity. USP <661.2> addresses plastic packaging systems, covering the finished system as used. USP <1663> and <1664> describe extractables and leachables assessment. We covered the US framework in more detail in our USP <661> compliance guide.

Europe — European Pharmacopoeia. EP chapter 3.1 covers materials of construction, with specific monographs for common polymers. EP 3.2 covers containers and closures produced from these materials. The structure is comparable to USP but the test methods and acceptance criteria differ in detail.

Japan — Japanese Pharmacopoeia. The JP general rules for containers and packaging cover plastic containers with their own test set, including extraction tests with defined solvents and reference limits.

China — Chinese Pharmacopoeia. The Chinese Pharmacopoeia addresses packaging materials and containers, and NMPA registration requirements add a separate administrative layer for packaging materials used with registered products.

Comparison Overview

The most significant practical difference is China's administrative registration layer, which requires documentation and approval beyond compendial testing.

What This Means for Packaging Specification

For a multi-market product, packaging decisions should account for:

• The most demanding compendial test set among the target markets
• Whether a material's documentation covers all four frameworks
• Whether additional administrative registration is required in China
• Whether testing done for one framework can be accepted for another

Where frameworks overlap substantially, a single test program can often satisfy several of them — but this should be confirmed with regulatory affairs early rather than assumed.

Documentation to Request

Ask your packaging supplier for compendial compliance statements covering the frameworks relevant to your markets, together with material composition information, batch certificates of analysis, and a change control commitment. Our standard package covers USP, EP, and CP requirements — details are on the certifications page.

For multi-market submission support, contact our regulatory team to discuss what documentation we can provide for your specific products.