Article 11U.K.Assessment by the rapporteur Member State and the co-rapporteur Member State
1.Where the application is admissible in accordance with Article 8(1), the rapporteur Member State shall, after consulting the co-rapporteur Member State, at the latest 12 months after the date referred to in Article 6(3), prepare and submit to the Commission, with a copy to the Authority, a report assessing whether the active substance can be expected to meet the approval criteria, as provided for in Article 4 of Regulation (EC) No 1107/2009 (‘the draft renewal assessment report’).
2.The draft renewal assessment report shall also include the following:
(a)a recommendation with regard to the renewal of the approval;
(b)a recommendation on whether the substance should be considered a ‘low-risk’ substance;
(c)a recommendation on whether the substance should be considered a candidate for substitution;
(d)where relevant, a proposal to set maximum residue levels;
(e)where relevant, a suggestion for the classification or reclassification of the active substance in accordance with Regulation (EC) No 1272/2008;
(f)a conclusion on which of the new studies included in the supplementary dossiers are relevant for the assessment;
(g)a recommendation as to the parts of the report on which a consultation of experts is to be organised in accordance with Article 13(1);
[F1(h) the points on which the co-rapporteur Member State did not agree with the assessment by the rapporteur Member State, where relevant, or, where applicable, the points where there is no agreement between Member States forming a group of Member States acting jointly as rapporteur Member State.]
3.The rapporteur Member State shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge. It shall take into account the supplementary dossiers, and, where appropriate, the dossiers submitted for the approval and subsequent renewals of approval.
4.The rapporteur Member State shall first establish whether the approval criteria set out in points 3.6.2, 3.6.3, 3.6.4 and 3.7 of Annex II to Regulation (EC) No 1107/2009 are satisfied.
Where those criteria are not satisfied, the draft renewal assessment report shall be limited to those parts of the assessment, unless Article 4(7) of Regulation (EC) No 1107/2009 applies.
5.Where the rapporteur Member State requires additional information, it shall set a period for the applicant to supply that information. That period shall not lead to an extension of the period of 12 months provided for in paragraph 1. The applicant may, pursuant to Article 63 of Regulation (EC) No 1107/2009, request such information to be kept confidential.
6.The rapporteur Member State may consult the Authority and request additional technical or scientific information from other Member States. Such consultations and requests shall not lead to an extension of the period of 12 months provided for in paragraph 1.
7.Information submitted by the applicant without having been requested, or provided after the expiry of the period set for its submission in accordance with the first sentence of paragraph 5, shall not be taken into account, unless it is submitted in accordance with Article 56 of Regulation (EC) No 1107/2009.
8.When submitting the draft renewal assessment report to the Commission, the rapporteur Member State shall request the applicant to submit the supplementary summary dossiers, updated to include the additional information requested by the rapporteur Member State in accordance with paragraph 5 or submitted in accordance with Article 56 of Regulation (EC) No 1107/2009, to the co-rapporteur Member State, the Commission, the other Member States and to the Authority.
The applicant may pursuant to Article 63 of Regulation (EC) No 1107/2009 request such information to be kept confidential. Any such requests shall be addressed to the Authority.
Textual Amendments
F1 Substituted by Commission Implementing Regulation (EU) 2019/724 of 10 May 2019 amending Implementing Regulation (EU) No 686/2012 as regards the nomination of rapporteur Member States and co-rapporteur Member States for the active substances glyphosate, lambda-cyhalothrin, imazamox and pendimethalin and amending Implementing Regulation (EU) No 844/2012 as regards the possibility that a group of Member States assumes jointly the role of the rapporteur Member State (Text with EEA relevance).