Article 12
Presentation of a draft directive or draft decision At the latest six months after receipt of the EFSA opinion referred to in Article 11(4) the Commission shall submit a draft review report. Without prejudice to any proposal it may submit with a view to amending the Annex to Directive 79/117/EEC, and on the basis of the finalised review report it shall submit to the Committee: (a) a draft directive to include the active substance in Annex I to Directive 91/414/EEC, setting out where appropriate the conditions, including the time limit, for such inclusion; or (b) a draft decision addressed to the Member States to withdraw the authorisations of plant-protection products containing the active substance, pursuant to the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, whereby that active substance is not included in Annex I to Directive 91/414/EEC, mentioning the reasons for the non-inclusion. The directive or decision shall be adopted in accordance with the procedure provided for in Article 19 of Directive 91/414/EEC.