Meaning
Federal regulation 21 CFR 177 1520 provides the compliance framework for olefin polymers intended for food contact applications. This specific regulation dictates the purity and solubility standards for resins such as polyethylene and polypropylene. It establishes extractability limits in various solvents to ensure that plastic components do not transfer harmful substances to food.
Adherence to these specifications is mandatory for resin manufacturers seeking to sell materials into the food packaging or medical device markets.
Compliance Requirement
Safety thresholds for extractables are defined by the end-use temperature and the type of food involved. Materials governed by 21 cfr 177 1520 must undergo testing for n-hexane and xylene solubility. These tests quantify the amount of non-polymeric material that can migrate under specific conditions.
A resin that fails these limits cannot be certified for food contact despite having excellent mechanical properties.
Moulding Suitability
Processing temperatures often impact the final extractable profile of the part. While the raw resin meets 21 cfr 177 1520, improper moulding conditions like excessive heat or shear can degrade the polymer chains. This degradation creates smaller molecules that increase the likelihood of failing migration tests.
Documentation from the resin supplier must match the specific grade and density used in the production run.
Regulatory Scope
The standard covers homopolymers, copolymers, and blends within the polyolefin family. Different sub-clauses in 21 cfr 177 1520 apply depending on whether the part is a film or a rigid container. Additives like slip agents and antioxidants are often regulated separately but must be compatible with the overall olefin entry.
Verification of the final product ensures that the polymer remains safe throughout its lifecycle.
