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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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#LAUSgroup #FoodContactMaterial #genotoxicity

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