EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11271/2018 
[…](2018) XXX  draft 
ANNEXES 1 to 2 
 
ANNEXES 
to the 
COMMISSION IMPLEMENTING REGULATION (EU) .../... 
renewing the approval of the active substance tolclofos-methyl 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 
Tolclofos-methyl 
CAS No 57018-04-9 
CIPAC No 479  O-2,6-dichloro-p-tolylO,O-
dimethyl phosphorothioate 
O-2,6-dichloro-4-methylphenyl 
O,O-dimethyl phosphorothioate  ≥ 960 g/kg  
 
The following impurity 
is of toxicological 
concern and must not exceed the following level in the technical material: 
 
Methanol max. 1 g/kg
 1 August 2019 31 July 2034 Only for use on ornamentals and on potatoes. 
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 tolclofos-methyl, 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 and mammals; 
- the risk to consumers
, in particular  the potential 
risk from metabolite DM-TM-CH 2OH in potatoes; 
- the risk to operators, workers and bystanders. 
Conditions of use shall include risk mitigation measures, 
where appropriate. 
 
                                                 
1 Further details on identity and specification of 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 126 on tolc lofos-methyl 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 Tolclofos-methyl 
CAS No 57018-04-9 
CIPAC No 479  O-2,6-dichloro-p-
tolylO,O-dimethyl phosphorothioate 
O-2,6-dichloro-4-
methylphenyl O,O-dimethyl phosphorothioate
 ≥ 960 g/kg  
 
The following impurity 
is of toxicological 
concern and must not 
exceed the following level in the technical material: 
 
Methanol max. 1 g/kg
 1 August 2019 31 July 2034 Only for use on ornamentals and on potatoes. 
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 tolclofos-methyl, 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 and mammals; 
- the risk to consumers
, in particular  the potential 
risk from metabolite DM-TM-CH 2OH in potatoes; 
- the risk to operators to operators, workers and 
bystanders; 
Conditions of use shall include risk mitigation measures, 
where appropriate." 
 
                                                 
2 Further details on identity and specification of active substance are provided in the review report.