ANNEX IISupplementary provisions
ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 96 on methoxyfenozide is deleted; (2) in Part E, the following entry is added: No. Common Name, Identification Numbers IUPAC Name Purity ( 1 ) Date of approval Expiration of approval Specific provisions ‘11 Methoxyfenozide CAS No 161050-58-4 CIPAC No 656 N-tert-Butyl-N′-(3-methoxy-o-toluoyl)-3,5-xylohydrazide ≥ 970 g/kg The following impurities must not exceed the following levels in the technical material: Tert-butylhydrazine < 0,001 g/kg RH-116267 < 2 g/kg 1 April 2019 31 March 2026 Only uses in greenhouses shall be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methoxyfenozide, and in particular Appendices I and II thereto, shall be taken into account. In their overall assessment Member States shall pay particular attention to: — the protection of groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions; — the risk of accumulation in soil; — the protection of non-target arthropods, sediment dwelling and aquatic organisms; Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. a comparative in vitro metabolism study on methoxyfenozide, by 1 April 2020; 2. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water, within 2 years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. The applicant shall also provide an updated assessment of the information submitted and, where relevant, further information to confirm the absence of thyroid endocrine activity in accordance with Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 ( 2 ) by 1 February 2021. ( 1 ) Further details on identity and specification of active substance are provided in the review report. ( 2 ) Commission 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 ).’