EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12148/2020 Rev. 2  
[…](2020) XXX  draft  
ANNEXES 1 to 2  
 
ANNEXES  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) .../...  
amending Implementing Regulations (EU) No 540/2011 and (EU) No 820/2011 as 
regards the conditions of approval of the active substance terbuthylazine  
   
EN 1  EN ANNEX I  
Annex I to Implementing Regulation (EU) No 820/2011  is replaced by the following : 
Common Name,  
Identification Numbers  IUPAC Name  Purity1 Date of 
approval  Expiration 
of approval  Specific provisions  
Terbuthylazine   
CAS No  
5915 -41-3 
CIPAC No 234 N2-tert-butyl -6-
chloro -N4-ethyl -1,3,5 -
triazine -2,4-diamine  ≥ 950 g/kg  
The following 
impurities are of 
toxicological concern 
and must not exceed the 
following levels in the 
technical material:  
– Propazine: 
maximum of 9 g/kg  
– Atrazine : maximum 
of 1 g/kg  
– Simazine: maximum 
of 9 g/kg  
 1 January  
2012 31 
December 
2024 PART A  
Only uses as herbicide  may be authorised.   
Use shall be limited to one application every three years 
on the same field at a maximum dose of 850  g 
terbuthylazine per hectare.  
 
PART B  
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 
terbuthylazine,  and in particular Appendices I and II 
thereof , as finalised in the Standing Committee on the 
Food Chain and Animal Health on 17 June 2011 and 
updated by the Standing Committee on Plants, Animals, 
Food and Feed on XX XXX  2021 shall be taken in to 
account.  
In this overall assessment Member States shall  pay 
particular attention to:  
(a) the consumer risk assessment from exposure to 
metabolites of terbuthylazine;  
(b) the protection of groundwater, when the active 
substance is applied in regions with vulnerable 
soil and/or climatic conditions;  
(c) the risk to mammals and earthworms . 
 
                                                 
1 Further details on identity and specification of active substance are provided in the review report .  
EN 2  EN Common Name,  
Identification Numbers  IUPAC Name  Purity1 Date of 
approval  Expiration 
of approval  Specific provisions  
Conditions of use shall include risk mitigation measures  
and the obligation to carry out  monitoring programmes to 
verify potential groundwater contamination in vulnerable 
zones, where appropriate . 
 
  
EN 3         EN ANNEX II 
Entry 16, on terbuthylazine, in Part B of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:  
Number  Common 
Name,  
Identification 
Numbers  IUPAC Name  Purity2 Date of approval  Expiration of 
approval  Specific provisions  
16 Terbuthylazine   
CAS No  
5915 -41-3 
CIPAC No 234 N2-tert-butyl -6-
chloro -N4-ethyl -
1,3,5 -triazine -2,4-
diamine  ≥ 950 g/kg  
The following 
impurities are of 
toxicological concern 
and must not exceed the 
following levels in the 
technical material:  
– Propazine: 
maximum of 9 g/kg  
– Atrazine : maximum 
of 1 g/kg  
– Simazine: maximum 
of 9 g/kg  
 1 January  2012 31 December 
2024 PART A  
Only uses as herbicide  may be authorised.   
Use shall be limited to one application every three years 
on the same field at a maximum dose of 850  g 
terbuthylazine per hectare.  
 
PART B  
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 
terbuthylazine,  and in particular Appendices I and II 
thereof, as finalised in the Standing Committee on the 
Food Chain and Animal Health on 17 June 2011 and 
updated by the Standing Committee on Plants, Animals, 
Food and Feed on XX XXX  2021  shall be taken into 
account.  
In this overall assessment Member States shall  pay 
particular attention to:  
(a) the consumer ri sk assessment from exposure to 
metabolites of terbuthylazine;  
(b) the protection of groundwater, when the active 
substance is applied in regions with vulnerable 
soil and/or climatic conditions;  
                                                 
2 Further details on identity and specification of active substance are provided in the review report .  
EN 4         EN Number  Common 
Name,  
Identification 
Numbers  IUPAC Name  Purity2 Date of approval  Expiration of 
approval  Specific provisions  
(c) the risk to mammals and earthworms . 
 
Conditions of use shall inclu de risk mitigation measures  
and the obligation to carry out  monitoring programmes to 
verify potential groundwater contamination in vulnerable 
zones, where appropriate .