Article 11 Draft assessment report

Within 12 months of the date of the notification provided for in the first subparagraph of Article 9(3), the F1assessing competent authority shall prepare and submit to the F2other competent authorities a report, referred to as the ‘draft assessment report’, assessing whether the active substance can be expected to meet the approval criteria provided for in Article 4.

The draft assessment report shall also include where relevant, a proposal to set maximum residue levels.

The F3assessing competent authority shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge.

Where, pursuant to Article 4(1), the assessment establishes that the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are not satisfied, the draft assessment report shall be limited to those parts of the assessment.

Where the F4assessing competent authority needs additional studies or information, it shall set a period in which the applicant must supply those studies or that information. In that case, the 12-month period shall be extended by the additional period granted by the assessing competent authority. The additional period shall be of a maximum of 6 months and shall cease at the moment when the additional information is received by the assessing competent authority. It shall inform the F5other competent authorities accordingly.

Where at the end of the additional period, the applicant has not submitted the additional studies or information, the F6assessing competent authority shall inform the applicant F7and the other competent authorities, and shall state the missing elements in the assessment included in the draft assessment report.

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