EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11110/2019 Rev 1  
[…](2019) XXX  draft  
ANNEXES 1 to 2  
 
ANNEXES  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) .../...  
renewing the approval of the active substance metalaxyl -M, and restricting the use of 
seeds treated with plant protection products containing it, in accordance with 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council 
concerning the p lacing 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  
Metalaxyl -M 
 
CAS No 70630 -17-0 (R)  
CIPAC No 580  methyl N -
(methoxyacetyl)
-N-(2,6-xylyl) -
D-alaninate  
 
 920 g/kg  
 
The following 
impurities are of 
toxicological concern 
and must not exceed 
the following levels in 
the technical material : 
 
2,6-
dimethylphenylamine:  
max. content 0.5  g/kg 
 
4-methoxy -5-
methyl -5H-
[1,2]oxathiole 2,2 -
dioxide : 
max. content 1 
g/kg  
 
2-[(2,6 -dimethyl -
phenyl) -(2-
methoxyacetyl) -
amino] -propionic 
acid 1-
methoxycarbonyl -
ethyl ester :  
max. content 
0.18 g/kg 1 April  2020  31 March  2035 Use as seed treatment is permitted, however, treated seeds shall only be 
sown in greenhouses.  
 
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 metalaxyl -M, and in particular Appendices  I and II 
there to, shall be taken into account.  
In this overall assessment Member States shall pay particular attention 
to: 
– the specification of the technical material as commercially 
manufactured;  
– the protection of  operators  and workers , ensuring that the conditions 
of use prescribe the use of adequate personal protective equipment, 
where appropriate;  
– the protection of groundwater, when the substance is applied in 
regions with vulnerable soil and/or climatic conditi ons; 
– the protection of non -target arthropods, birds and mammals . 
 
Conditions of use shall include risk mitigation measures, where 
appropriate.  
 
The applicant shall submit to the Commission, the Member States and 
the Authority an updated assessment of the i nformation submitted and, 
where relevant, further information to confirm the absence of endocrine 
activity in accordance with points 3.6.5 . and 3.8.2 . of Annex  II to 
Regulation (EC) No 1107/2009, as amended by Regulation (EU) 
2018/605 by … [Publication Office please insert the date 
corresponding to  2 years from the date of entry into force ]. 
 
                                                 
1 Further details on the identity and the specification of the active substance are provided in the review report.   
EN 2  EN ANNEX II 
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:  
(1) in Part A, entry 37 on metalaxyl -M is deleted;  
(2) in Part B, the following entry is added:  
No. Common 
Name,  
Identification 
Numbers  IUPAC 
Name  Purity2 Date of 
approval  Expiration of 
approval  Specific provisions  
'XXX  Metalaxyl -M 
 
CAS No 
70630 -17-0 
(R) 
CIPAC No 
580 methyl N -
(methoxyac
etyl)-N-
(2,6-xylyl) -
D-alaninate  
 
 920 g/kg  
 
The following impurities are 
of toxicological concern and 
must not exceed the 
following levels in the 
technical material : 
 
2,6-dimethylphenylamine:  
max. content 0.5  g/kg 
 
4-methoxy -5-methyl -
5H-[1,2]oxathiole 2,2 -
dioxide : 
max. content 1 g/kg   
 
2-[(2,6 -dimethyl -
phenyl) -(2-
methoxyacetyl) -amino] -
propionic acid 1 -
methoxycarbonyl -ethyl 
ester :  
max. content 0.18 g/kg  1 April  2020  31 March  2035 Use as seed treatment is permitted, however, treated seeds shall only be 
sown in greenhouses.  
 
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 metal axyl-M, and in particular Appendices  I and II 
there to, shall be taken into account.  
In this overall assessment Member States shall pay particular attention 
to: 
– the specification of the technical material as commercially 
manufactured;  
– the protection of operators  and workers , ensuring that the conditions 
of use prescribe the use of adequate personal protective equipment, 
where appropriate;  
– the protection of groundwater, when the substance is applied in 
regions with vulnerable soil and/or climatic conditio ns; 
– the protection of non -target arthropods, birds and mammals . 
 
Conditions of use shall include risk mitigation measures, where 
appropriate.  
 
The applicant shall submit to the Commission, the Member States and 
the Authority an updated assessment of the in formation submitted and, 
where relevant, further information to confirm the absence of endocrine 
activity in accordance with points 3.6.5 . and 3.8.2 . of Annex  II to 
                                                 
2 Further details on  the identity and the specification of the active substance are provided in the review report.   
EN 3  EN No. Common 
Name,  
Identification 
Numbers  IUPAC 
Name  Purity2 Date of 
approval  Expiration of 
approval  Specific provisions  
Regulation (EC) No 1107/2009, as amended Regulation (EU) 2018/605 
by …[Publication Office p lease insert the date corresponding to  2 
years from the date of entry into force ].ʼ