Meaning
Safety thresholds dictate the maximum allowable concentration of a specific chemical substance that can transfer from a plastic food contact material into food or food simulants. Known as the EU 10 2011 specific migration limit, this statutory constraint is expressed in milligrams of substance per kilogram of foodstuff. Compliance ensures that plastic packaging does not alter food composition or bring about unacceptable changes in taste or odor.
Migration Limit
Specific migration values are listed in the union list of authorized substances for plastic packaging materials. Within the framework of the EU 10 2011 specific migration limit, each restricted substance has a value assigned based on toxicological evaluation of risk. Monomers like bisphenol A or plasticizers like phthalates face extremely low limits due to their high toxicity.
Standardized plastic formulations use these values to ensure that additives remain bound within the polymer matrix.
Laboratory Verification
Testing agencies perform extraction experiments to measure chemical transfer under controlled conditions. High performance liquid chromatography or gas chromatography coupled with mass spectrometry measures the amount of substance that migrates into food simulants like ethanol or acetic acid. The regulatory test designed for the EU 10 2011 specific migration limit uses defined temperature and time exposures to simulate real world storage.
Passing these tests requires precise control of polymer compounding and processing temperatures to avoid thermo oxidative degradation of the resin.
Moulder Duty
Processors must obtain a declaration of compliance from their raw material suppliers. When a processor uses recycled resin or introduces colorants, they must verify that the EU 10 2011 specific migration limit is not exceeded in the finished article. Moulders can achieve this through mathematical diffusion modeling or direct laboratory testing of the final molded part.
Responsibility for food safety sits firmly with the manufacturer of the finished article.
