3.The recipient or parental strain/cell line should have proven and extended history of safe use or built-in biological barriers, which, without interfering with optimal growth in the reactor or fermentor, confer limited survivability and replicability, without adverse consequences in the environment (applicable only for type B operations).
Prejemni ali starševski sev/celična linija mora imeti dokazano in obširno zgodovino varne uporabe ali vgrajene biološke pregrade, ki ne ovira optimalne rasti v bioreaktorju ali fermentorju, ki daje omejeno sposobnost preživetja in podvajanja brez škodljivih posledic v okolju (uporablja se samo za postopke vrste B).