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.
Article 16 Supporting Documentation
Meaning
A detailed technical file compiled by a manufacturer contains the test results, chemical risk assessments, and experimental data that prove the validity of a compliance declaration. This Article 16 Supporting Documentation must be made available to national enforcement authorities upon request to verify the assertions in the conformity certificate. It justifies the material safety without disclosing trade secrets to the general market.
Technical Record
The file includes detailed reports on migration testing, calculations of exposure, and toxicological assessments of any non-intentional additives. It specifies the conditions of the test, such as the duration, temperature, and specific food simulants employed in the laboratory. The documents must demonstrate that the limits of migration are not exceeded under the most severe foreseeable conditions of use.
Audit Trail
This record maintains the trace of the manufacturing history and raw material sourcing. It connects each batch of resin to the original supplier certificates and any chemical analysis. This structure allows regulators to trace the origins of a potential contamination event and to verify that the quality control system is functioning correctly.
Industrial Context
Manufacturers must compile this file before placing the product on the market. It must be updated continuously as formulations change.