Z odstopanjem od odstavka 1 in brez poseganja v določbe odstavkov 3 in 4 se vlagatelja lahko izvzame iz obveznosti predložitve zahtevanih podatkov odstavka 1(b), razen podatkov za ugotovitev istovetnosti aktivne snovi, če je aktivna snov že uvrščena v Prilogo I, ob upoštevanju pogojev za uvrstitev v Prilogo I, in če se stopnja čistosti in vrsta nečistot bistveno ne razlikuje od sestave, navedene v dokumentaciji k prvotnem zahtevku.
By way of derogation from paragraph 1, and without prejudice to the provisions of paragraphs 3 and 4, applicants shall be exempted from supplying the information required under paragraph 1 (b) except for that identifying the active substance if the active substance is already listed in Annex I, taking into account the conditions of inclusion in Annex I, and does not differ significantly in degree of purity and nature of impurities, from the composition registered in the dossier accompanying the original application.