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: existing MRLs for that active substance set out in Annex II or III to this Regulation; the necessity of setting new MRLs for that active substance, or its inclusion in Annex IV to this Regulation; specific processing factors as referred to in Article 20(2) of this Regulation that may be needed for that active substance; 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.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-30 · Text as adopted (Official Journal); later amendments are not incorporated in this text.