Division 2

In evaluating applications for granting authorisations F1competent authorities shall:

1. (a)

   • ensure that dossiers on microbial plant protection products supplied are in accordance with the requirements of part B of the Annex to Regulation (EU) No 545/2011, at the latest at the time of finalisation of the evaluation for the purpose of decision-making, without prejudice, where relevant, to Articles 33, 34 and 59 of Regulation (EC) No 1107/2009,

   • ensure that the data submitted are acceptable in terms of quantity, quality, consistency and reliability and sufficient to permit a proper evaluation of the dossier,

   • evaluate, where relevant, justifications submitted by the applicant for not supplying certain data;

2. (b)

   take into account the data referred to in part B of the Annex to Regulation (EU) No 544/2011, concerning the active substance consisting of micro-organisms (including viruses) in the plant protection product, submitted for the purpose of approval of the micro-organism concerned as active substances under Regulation (EC) No 1107/2009, and the results of the evaluation of those data, without prejudice, where relevant, to Article 33(3) and Articles 34 and 59 of Regulation (EC) No 1107/2009;

3. (c)

   take into consideration other relevant technical or scientific information they can reasonably possess with regard to the performance of the plant protection product or to the potentially adverse effects of the plant protection product, its components or its metabolites/toxins.