Regulatory Scope
Legal compliance for food contact materials relies on fda 21 cfr 176-170 to define the chemical constituents permitted in components of paper and paperboard products. This regulation identifies specific substances allowed in the formulation of packaging intended for aqueous and fatty foods. Manufacturers must ensure that any additive utilized during the production of paper liners or wrappers meets the purity criteria and quantitative limits specified in the text.
Substances listed here undergo rigorous toxicological review to confirm that migration levels remain within safe tolerances for human consumption.
Compliance Requirement
Documentation supporting a claim of safety under fda 21 cfr 176-170 typically involves a letter of guaranty from the chemical supplier. Converters generate this assurance by verifying that the components used in their adhesives or coatings appear on the positive list maintained by the agency. Testing protocols often involve migration studies using food simulants to measure the amount of material transferring from the substrate to the food contact surface.
Results from these extraction tests provide the basis for confirming that the additive concentration stays beneath the maximum levels established for specific food types. Accuracy in record keeping prevents the inclusion of restricted chemicals in food-grade packaging.
Operational Boundary
Performance standards for additives change when the substrate undergoes secondary processing like lamination or printing. Functional barriers located between the food and the paperboard may alter the applicability of fda 21 cfr 176-170, as these layers change the potential for chemical migration. Mill operations focus on controlling the grammage and chemical treatment of the pulp to maintain consistency within the defined thresholds.
Additives not listed in this specific section may find authorization under different parts of the code of federal regulations if they serve a different purpose or function as an indirect food additive. Verification of the total migration limit remains the final check for safety in all food-contact paper applications.
