Safety Assessment
Conservative simulation approach used to estimate the maximum possible chemical migration from packaging into food assumes no functional barrier exists and all substances migrate fully. This method, termed worst case modelling, provides an initial regulatory screening tool to quickly prove compliance when actual migration is guaranteed to fall below legal thresholds. It avoids the need for complex and costly experimental testing in clear-cut safety cases.
Calculation Method
Assuming that all of the migrant is transferred into the foodstuff simplifies the calculation by removing diffusion rates from the equation. During worst case modelling, the calculation depends solely on the initial concentration of the substance in the polymer and the volume of food in contact with it. This creates a highly protective safety margin.
Regulatory Utility
Packaging manufacturers and food brand owners rely on this simplified approach to demonstrate the safety of their products under extreme storage conditions. When worst case modelling demonstrates that even total migration remains below the specific migration limits, the material is deemed compliant without further analytical work. This streamlined validation process is highly valuable for rapid product development cycles where testing bottlenecks must be avoided.
If the simulated migration exceeds the legal limit, the manufacturer must then proceed to more refined mass transfer modeling or direct laboratory testing to prove compliance.
