
Article 1 
The approval of the active substance methoxyfenozide, as a candidate for substitution, is renewed as set out in Annex I.
Article 2 
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 3 
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 April 2019.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 31 January 2019.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX I

Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
MethoxyfenozideCAS No 161050-58-4CIPAC No 656 N-tert-Butyl-N′-(3-methoxy-o-toluoyl)-3,5-xylohydrazide ≥ 970 g/kgThe 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, by 1 February 2021.


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 Date of approval Expiration of approval Specific provisions
‘11 MethoxyfenozideCAS No 161050-58-4CIPAC No 656 N-tert-Butyl-N′-(3-methoxy-o-toluoyl)-3,5-xylohydrazide ≥ 970 g/kgThe 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 by 1 February 2021.


