Regulation 10/2011

Material Composition

Manufacturers verify compliance through migration testing protocols conducted under standardized conditions that simulate real-world usage durations and temperature ranges. Resin suppliers and converters perform these tests using food simulants like ethanol or vegetable oil to extract potential contaminants from the substrate under worst-case scenarios. A laboratory measures the mass of migrated compounds against the permissible limit of ten milligrams per square decimeter of the surface area.

High-performance liquid chromatography or gas chromatography identifies the specific monomers and additives present within the extract, ensuring every ingredient stays within the authorized list of positive chemicals. Converters select barrier coatings and adhesives based on their potential for migration, as even trace amounts of uncured components can exceed the safety thresholds during the shelf life of the packed item. Testing frequency depends upon the production consistency and the potential for batch-to-batch variation in the raw plastic resins.

Regulatory Scope

The requirements enforce accountability across the entire supply chain by demanding documentation that travels from the chemical plant to the final food processor. Paper converters producing sandwich wraps or paper-backed plastic laminates use the declaration of compliance to confirm that their materials do not pose a toxicological risk when used according to the technical specifications. The regulation mandates that the total quantity of non-listed substances remains below detectable levels during the lifecycle of the packaging.

Proper documentation proves that the plastic content conforms to established safety benchmarks.