EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10294/2018 rev 1  
[…](2018) XXX  draft  
ANNEXES 1 to 2  
 
ANNEXES  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) .../...  
of XXX  
renewing the approval of the active substance methoxyfenozide, as a candidate for 
substitution, in accordance with Regulation (EC) No 1107/2009 of the European 
Parliament and of the Council concerning the placing of plant protection products on 
the market,  and amending the Annex to Commission Implementing Regulation (EU) No 
540/2011    
EN 1  EN ANNEX I 
Common Name,  
Identification 
Numbers  IUPAC Name  Purity1 Date of 
approval  Expiration of 
approval  Specific provisions  
Methoxyfenozide  
CAS No 161050 -58-4 
CIPAC No 656  N-tert-Butyl -N’-
(3-methoxy -o-
toluoyl) -3,5-
xylohydrazide  ≥ 970  g/kg 
 
Tert-
butylhydrazine 
< 0.001 g/kg 
RH-116267 
< 2 g/kg  1 February  2019  31 January 2026  Only uses on fruiting vegetables of solanaceae  in greenhouse 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 th ereto , 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 
confirm atory information as regards:  
1. a comparative in vitro metabolism study on methoxyfenozide , by 1 February 
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 ; 
3. the endocrine disrupting potential of methoxyfenoz ide as regards the thyroid 
modality/pathway , providing in particular mechanistic data to clarify 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) 2018/6052, whether 
there is a t hyroid endoc rine disrupting  mode of action , by 10  November  2020 . 
 
                                                 
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.).   
EN 2  EN 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  Purity3 Date of 
approval  Expiration of 
approval  Specific provisions  
"xx Methoxyfenozide  
CAS No 161050 -58-4 
CIPAC No 656  N-tert-Butyl -
N’-(3-
methoxy -o-
toluoyl) -3,5-
xylohydrazide  ≥ 970  g/kg 
 
Tert-
butylhydrazine 
< 0.001 g/kg 
RH-116267 
< 2 g/kg  1 February  
2019  31 January 2026  Only uses on fruiting vegetables of solanaceae in greenhouse 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 Mem ber 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 February 
2020 ; 
2. the effect of water treatment processes on the nature of residues present in 
surface and groundwater, when surface water or groundwater is abstrac ted 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;  
3. the endocrine disrupting potential of methoxyfenozide as regards the thyroid 
modality/pathway, providing in particular mechanistic data to clarify 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) 2018/6054, whether 
there is a thyroid endocrine disrupting  mode of action,  by 10  November  2020. " 
 
                                                 
3 Further details on identity and specification of active substance are provided in the review report . 
4  Commiss ion Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific cri teria for the determination of 
endocrine disrupting properties. (OJ L 101, 20.4.2018, p. 33.).