von LAUS (BD)
New Registrants of an Existing Substance (NRES)
For Plastic Food Contact Materials EFSA requires genotoxicity testing including a minimum of two in vitro studies:
i) A bacterial reverse mutation test
ii) An in vitro mammalian cell micronucleus test
In a first step the specific migration limits (SML) expressed in mg of substance per kg of food (mg/kg) needs to be determined for the packaging material. If the exposure through migration is low, this limited data set might be sufficient. If the exposure is higher, a strategy with more toxicological information will be required.
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