For the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 as amended by Commission Regulation (EU) 2018/605(1), in relation to applications submitted in accordance with Article 1 before 10 November 2018 for which the draft renewal assessment report has not been submitted by that date, where the information available in the supplementary dossiers is not sufficient for the [F2assessing competent authority] to conclude the assessment on whether these approval criteria are met and, where applicable, whether application of Article 4(7) is justified, the [F2assessing competent authority] shall specify in the draft renewal assessment report, in a detailed way, the additional information which is necessary in order to make the assessment concerned.]
Textual Amendments
F1Inserted by Commission Implementing Regulation (EU) 2018/1659 of 7 November 2018 amending Implementing Regulation (EU) No 844/2012 in view of the scientific criteria for the determination of endocrine disrupting properties introduced by Regulation (EU) 2018/605 (Text with EEA relevance).
F2Words in Art. 11a substituted (31.12.2020) by The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 (S.I. 2019/559), regs. 1(3), 11(2); 2020 c. 1, Sch. 5 para. 1(1)
[F1Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties ( OJ L 101, 20.4.2018, p. 33 ).]
Textual Amendments