1. The Authority shall, within a period of 12 months from the date of the inclusion or non-inclusion of an active substance in Annex I to Directive 91/414/EEC after the entry into force of this Regulation, submit a reasoned opinion based in particular on the relevant assessment report prepared under Directive 91/414/EEC to the Commission and the Member States on:
(a)
existing MRLs for that active substance set out in Annex II or III to this Regulation;
(b)
the necessity of setting new MRLs for that active substance, or its inclusion in Annex IV to this Regulation;
(c)
specific processing factors as referred to in Article 20(2) of this Regulation that may be needed for that active substance;
(d)
MRLs which the Commission may consider including in Annex II and/or Annex III to this Regulation and on those MRLs which may be deleted related to that active substance.
2. For substances included in Annex I to Directive 91/414/EEC before the entry into force of this Regulation, the reasoned opinion referred to in paragraph 1 of this Article shall be delivered within 12 months of the entry into force of this Regulation.