Meaning
The section of the United States federal regulations that governs the safety of food contact materials, including plastics, additives, and adhesives, is the primary benchmark for packaging compliance. This regulatory framework, designated as us fda 21 cfr, establishes the conditions under which specific polymers may be safely used in food packaging. It lists the approved substances, the permitted purity levels, and the migration limits for various food types.
Compliance with these regulations is mandatory for any plastic packaging sold in the United States.
Material Authorization
The regulations specify the permitted composition of polymer compounds used in food-contact articles. Part 177 contains specific sections for different polymer types, such as polyethylene, polystyrene, and nylon. Each section defines the permitted starting monomers and any required extraction limits.
These extraction tests must be conducted using specified solvents to simulate actual use conditions.
Additive Regulation
Compounding additives, such as antioxidants, colorants, and plasticizers, are regulated under separate subparts of the regulation. Only substances that have been cleared or are subject to a prior sanction may be used. Manufacturers must ensure that the total concentration of these additives remains below the specified limits.
This ensures that the migration of these chemicals into food does not exceed safe levels.
Compliance Documentation
Producers must issue a declaration of compliance to their customers. This document references the specific parts of the regulation. It confirms that the material is compliant.
Traceability is maintained across the supply chain.
