EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11618/2017 rev 6  
[…](2018) XXX  draft  
ANNEXES 1 to 2  
 
ANNEXES  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) .../...  
renewing the approval of the active substance mepanipyrim 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 540/20    
EN 1  EN ANNEX I 
Common Name,  
Identification 
Numbers  IUPAC Name  Purity1 Date of 
approval  Expiration of 
approval  Specific provisions  
Mepanipyrim  
CAS No  110235 -47-7 
CIPAC No   611 N-(4-methyl -6-
prop-1-
ynylpyrimidin -2-
yl)aniline  ≥ 970 g/kg 
 
The following 
impurity  is of 
toxicological 
concern and 
must  not 
exceed the 
following level  
in the technical 
material:  
 
- toluene : 
maximum of 
5 g/kg 1 March  2019 28 February  2034 Only use s 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 
renewal  report on mepanipyrim , and in particular Appendices  I and II 
thereof, shall be taken into account.  
In this overall assessment Member States shall pay particular attention 
to: 
– the risk to aquatic organisms;  
– the risk to consumers , in particular  the potential risk from  
metabolite M31 ; 
– the risk to op erators and workers;  
– the toxicity profile of metabolite M31 (paying specific attention to 
potential degradation leading to aniline formation)  for uses other 
than the supported uses in Appendix II o f the renewal report ; 
– where applicable, the effect of water  treatment processes on the 
nature of residues present in surface water, when the surface water 
is abstracted for drinking water.  
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 in order to assess  the endocrine 
disrupting potential in accordance with points 3.6.5. and 3.8.2 of Annex 
II to Regulation (EC) No 1107/2009 , as amended by Commission 
Regulation (EU) 2018/6052, 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 scienti fic 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  90 on mepanipyrim is deleted;  
(2) in Part B, the following entry is added : 
 
No. Common Name,  
Identification 
Numbers  IUPAC Name  Purity3 Date of 
approval  Expiration of 
approval  Specific provisions  
‘XXX  Mepanipyrim  
CAS No 110235 -
47-7 
CIPAC No  611  N-(4-methyl -6-
prop-1-
ynylpyrimidin -2-
yl)aniline  ≥ 970 g/kg  
 
The following 
impurity is  of 
toxicological 
concern and 
must  not exceed 
the following 
level  in the 
technical 
material:  
 
- toluene: 
maximum of 
5 g/kg 1 March 2019 28 February  2034 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 re newal  report on 
mepanipyrim , and in particular Appendices  I and II thereof, shall be taken into 
account.  
In this overall assessment Member States shall pay particular attention to:  
– the risk to aquatic organisms;  
– the risk to consumers , in particular  the potential risk from  metabolite  M31 ; 
– the risk to operators and workers;  
– the toxicity profile of metabolite M31 (paying specific attention to 
potential  degradation leading to aniline formation)  for uses other than the 
supported uses in Appendix II of the renewal report ; 
– where applicable, the effect of water treatment processes on the nature of 
residues present in surface water, when the surface water is abstracted for 
drinking water.  
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 in order to assess t he endocrine disrupti ng 
potential in accordance with points 3.6.5. and 3.8.2 of Annex II to Regulation 
(EC) No 1107/2009 as amended by Commission Regulation (EU) 2018/6054, 
by 10  November  2020 .‘ 
 
                                                 
3 Further details on identity and specification of active substance are provided in the review report . 
4 Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scienti fic criteria for the determination of 
endocrine disrupting properties.  (OJ L 101, 20.4.2018, p. 33 ).