Global Legal Compliance Strategies for Packaging Materials | US

The United States has established requirements on food contact materials in chapter 21 of their Codes of Federal Regulations. Sections 175 to 182 cover a wide range of materials and substances and define the specifications as well as restrictions. Furthermore, the substances used in food contact materials can be exempted from individual FDA clearance provided that they are

• Generally recognized as safe (GRAS)
• Be already cleared prior to 1958
• Subject of a Food Contact Notification (FCN)
• Exposure of consumers is under a generally safe level (Threshold of regulation, TOR)

Furthermore, importers to the state of California need to consider California Proposition 65, the “Safe Drinking Water and Toxic Enforcement Act”. Consumers need to be warned in case a product contains substances which are known to cause cancer, birth defects or other reproductive harm. Certain substances listed in California Proposition 65 are subject to a safe harbour level which could relieve business operators from this duty provided consumer exposure is below this safe harbour level.