A Declaration of Conformity Covering Only the Base Polymer
Base polymer declarations certify monomer purity at the reactor gate but omit all converter additives, breakdown products, and finished article migration limits.
Annex I Positive List
Meaning
A regulatory schedule compiled by the European Commission establishes the authorized substances permitted for use in plastic food contact materials. Under Commission Regulation (EU) 10/2011, the Annex I Positive List designates monomers, additives, and polymer production aids that have undergone toxicological evaluation. Only these approved substances are permitted in the manufacture of food-grade plastics, establishing a strict limit on polymer formulations.
Substance Authorization
Chemical substances must satisfy specific purity requirements to maintain their approved status. If a compound is omitted from this registry, it cannot be used in food contact layers unless a specific exemption applies. Additives on the list are classified by their chemical identity and any restriction on their usage.
Migration Limit
The maximum allowable quantity of a substance that can transfer from the plastic packaging into food is governed by specific migration limits. These limits are expressed in milligrams of substance per kilogram of food stimulant, representing a protective cap designed to prevent exposure to potentially hazardous chemicals. Testing must simulate actual conditions of use, employing food simulants such as ethanol, acetic acid, or vegetable oil at specified temperatures and durations.
Compliance Verification
Verification requires a declaration of conformity supported by laboratory testing. Raw material suppliers must disclose the presence of restricted substances to downstream converters. This chain of documentation ensures that every actor in the supply chain can verify that the finished plastic article complies with the law.