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to assess the possible harmful effects of a food additive or derivatives thereof, it must be subjected to appropriate toxicological testing and evaluation.
zaradi možnih škodljivih učinkov aditiva za živila ali njegovih derivatov ga je treba ustrezno toksikološko pregledovati in ocenjevati.
the requirements of part i, module 4 of this annex on the pharmacological and toxicological testing of medicinal products may not always be appropriate due to unique and diverse structural and biological properties of advanced therapy medicinal products.
zahteve iz dela i, modula 4, te priloge o farmakološkem in toksikološkem preskušanju zdravil niso vedno primerne zaradi edinstvenih ter raznolikih strukturnih in bioloških lastnosti zdravil za napredno zdravljenje.
this shall include, on a case-by-case basis, an evaluation of their toxic potency and of the need of toxicological testing as well as a determination of their concentration in the genetically modified food and feed.
to vključuje oceno toksične potence za vsak primer posebej in potrebe po toksikološkem testiranju ter določitvi njihove koncentracije v gensko spremenjenih živilih in krmi.
non-exhaustive list of validated test methods for chemicals as provided by regulation (ec) no 440/2008 and which may be used in a possibly adapted form for gmo toxicological testing
neizčrpen seznam validiranih metod testiranja za kemikalije, kot je določen v uredbi (es) št. 440/2008 in se lahko uporablja v verjetno prilagojeni obliki za toksikološki test gso
where studies are conducted using an active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using the active substance as manufactured, unless it can be justified that the test material used is essentially the same, for the purposes of toxicological testing and assessment.
Študije, v katerih se uporablja aktivna snov, proizvedena v laboratoriju ali v poskusni proizvodnji, je treba ponoviti s tehnično aktivno snovjo, razen kadar je mogoče utemeljiti, da je uporabljena testna snov s stališča toksikološkega testa in ocene enaka.