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Showing posts with the label OM

Understanding ASTM, FDA, and EU Food Contact Material Testing Requirements

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For modern food packaging manufacturers, the landscape has shifted from a focus on shelf-life and aesthetics to surviving a regulatory minefield. The industry is currently grappling with a dual challenge: adhering to increasingly complex global safety standards while rapidly phasing out legacy materials, like Bisphenol A (BPA), in favor of safer alternatives. Section 1: The 2026 Regulatory Landscape (EU & FDA) Navigating international trade requires understanding fundamentally philosophies regarding food contact materials (FCMs). 1. The Precautionary Principle vs. Risk-Based Management EU (Precautionary Principle): The European Union operates on the basis that if an action or policy has a suspected risk of causing harm, the burden of proof that it is not harmful falls on those taking the action. This leads to swifter, blanket bans on specific chemicals. FDA (Risk-Based): The United States FDA ...

Navigating Residue on Evaporation, OM, and E&L

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In the highly regulated worlds of pharmaceutical and food packaging, the material " barrier property " is only half the story. While we often focus on what stays out (Oxygen and Moisture), it is equally critical to monitor what moves in—specifically, the migration of chemicals from the packaging material into the product. To ensure safety, the industry relies on a hierarchy of tests: Residue on Evaporation (ROE), Overall Migration (OM), and Extractables & Leachables (E&L). (AI generated image) 1. Defining the Terms While these terms can be confusing, they are essentially different "lenses" used to view the same physical phenomenon: the transfer of mass. Gravimetric Testing: This is the fundamental physical method. It involves using a high-precision microbalance to measure the weight of solids left behind after a solvent has been evaporated. Residue on Evaporation / Non-Vol...