Meaning
Federal regulations governing the use of polymers as indirect food additives establish the permitted materials and specifications for plastic packaging in the United States. Set forth in US FDA 21 CFR 177, this section lists the approved polymers, the required resins, and the extraction limits for finished food-contact articles. It covers many material classes, including olefin polymers, nylon, and polycarbonate.
Compliance is required for any polymer supplier or molder wishing to sell food-contact packaging in the US market.
Regulatory Framework
The regulation is organized by polymer type, with each section detailing the specific requirements for a particular resin. For example, section 1520 covers olefin polymers, while section 1500 covers nylon. Each section includes specifications for density, melting point, and maximum extractable fractions.
Extraction Testing
Finished articles must be tested for extraction using solvents like water, heptane, and alcohol under specified temperature and time conditions. These solvents simulate the different types of food that the plastic will package. The extracted residue must remain below the specified limits.
Process Control
Manufacturing facilities must maintain strict control over the molding process to ensure that the finished parts comply with the extraction limits. High melt temperatures or contamination can cause the parts to fail the extraction tests. This requires regular testing and documentation of the processing conditions.
