For de aktive stoffer, med hensyn til hvilke et eller flere dossierer betragtes som fuldstændige, foretager den rapporterende medlemsstat den vurdering, der er nævnt i artikel 10, medmindre EFSA senest to måneder efter at have modtaget medlemsstatens rapport underretter den rapporterende medlemsstat og Kommissionen om, at den ikke betragter dossieret som fuldstændigt.
For those active substances for which one or more dossiers are considered to be complete, the rapporteur Member State shall perform the evaluation as referred to in Article 10, unless the EFSA informs the rapporteur Member State and the Commission, within two months of receipt of the Member State report on completeness, that it does not consider the dossier to be complete.