EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/12148/2020 Rev.2  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulations (EU) No 540/2011 and (EU) No 820/2011 as 
regards the conditions of approval of the active substance terbuthylazine  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulations (EU) No 540/2011 and (EU) No 820/2011 as 
regards the conditions  of approval of the active substance terbuthylazine  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the  
Council of 21 October 2009 concerning the placing of plant protection products on the market 
and repealing Council Directives 79/117/EEC and 91/414/EEC1, and in particular the second 
alternative of Article 21(3) and Article 78(2)  thereof,  
Whereas:  
(1) Commiss ion Implementing Regulation (EU) No 820/20112 provides for the approval 
of the active substance terbuthylazine and the resulting insertion of terbuthylazine in 
the Annex to Commission Implementing Regulation (EU) No 540/20113. 
(2) Implementing Regulation (EU) No 820/2011 also provides for the submission of 
further confirmatory information  on the specification of the technical material, as 
commercially manufactured including information on the relevance of the impurities , 
the equivalence between the specifications of the technical material, as commercially 
manufactured, and the specifications of the test material used in the toxicity studies  
and the groundwater exposure assessment for the unidentified metabolites LM1, LM2,  
LM3, LM4, LM5 and LM6 . 
(3) In addition, Implementing Regulation (EU) No 820/2011  required  the applicant to 
submit  confirmatory information  as regards  the relevance of the metabolites MT1 MT 
13, MT14 and of the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6 
with respect to cancer, if terbuthylazine was classified under Regulation (EC) 
No 1272/2008  of the European Parliament and of the Council4 as ‘suspec ted of 
causing cancer’ . 
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Implementing Regulation (EU) No  820/2011 of 16  August 2011 approving the active 
substance terbuthylazine, in accordance with Regulation (EC) No  1107/2009 of the European 
Parliament and of the Council concerning the placing of plant protection pr oducts on the market, and 
amending the Annex to Commission Implementing Regulation (EU) No  540/2011 and Commission 
Decision 2008/934/EC (OJ L 209, 17.8.2011, p. 18).  
3 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulati on 
(EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active 
substances (OJ L 153, 11.6.2011, p. 1).  
4 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, 
p. 1). EN 2  EN (4) The applicant submitted additional information within the periods provided  for in 
Implementing Regulation (EU) No 820/2011. With regard to the relevance of specified 
metabolites of terbuthylazine if terbuthylazine was classified under Regulation (EC) 
No 1272/2008 as ‘suspected of causing cancer’ , the Risk Assessment Committee of 
the European Chemical s Agency adopted  on 5 June 2015  an opinion5 confirming that 
terbuthylazine is not to be classified as ‘suspected of causing cancer’ , rendering the 
corresponding confirmatory information  unnecessary.   
(5) The rapporteur Member State, the United Kingdom , assessed the additional 
information submitted by the applicant. It submitted its assessment, in the form of an 
addendum to the draft assessment report, to the other Member States, the Commission, 
and the European Food Safety Authority (‘the Authority’) on 6  August  2015.  
(6) The rapporteur Member State  consulted the other Member States, the applicant and the 
Authority and asked them to provide comments on the addendum to the draft 
assessment  report . The Authority published a technical report6 summ arising the 
outcome of this consultation for terbuthylazine on 20 January  2016 .  
(7) Taking into account the assessment of the rapporteur Member State and the  technical 
report the Commission considers that the requirement to submit confirmatory 
information on the specification of the technical material, as commercially 
manufactured , including information on the relevance of the impurities , and on  the 
equivalence between the specifications of the technical material, as commercially 
manufactured, and the specific ations of the test material used in the toxicity studies  
can be considered addressed , provided  the currently established maximum levels for  
the relevant impurities  propazine and simazine in the technical material as 
manufactured  are lowered .  
(8) The Commissio n further consulted the Authority in relation to the exposure of 
groundwater to  metabolites of terbuthylazi ne. The Authority published its updated 
conclusions  on the assessment of the additional information on 29 June 20177 and 
19 September  20198. The Authority identified  a risk to infant s and toddlers under 
some conditions of use from exposure to metabolites of terbuthylazine through food 
and drinking water, according to the additional informa tion provided by the applicant 
and based on the use of t erbuthylazine at a rate of 850  g/ha each year on the same 
field. Furthermore , where terbuthylazine  is applied every year at a maximum rate of 
850 g/ha, two metabolites of terbuthylazine, LM3 and LM6, are predicted to occur in 
groundwater  above 0.75 µg/L  in all scenarios , triggering the need for a consumer risk 
assessment which , however , could not be carried out since health -based reference 
values could not be deri ved based on the available data.  
                                                 
5 Opinion proposing harmonised classification and label ling at EU level of Terbuthylazine (ISO); N -tert-
butyl -6-chloro -N'-ethyl -1,3,5 -triazine -2,4-diamine EC Number: 227 -637-9 CAS Number: 5915 -41-3 
CLH -O-0000001412 -86-66/F. 
6 EFSA (European Food Safety Authority), 2016. Technical report on the outcome of the c onsultation 
with Member States, the applicant and EFSA on the pesticide risk assessment for terbuthylazine in light 
of confirmatory data. EFSA supporting publication 2016:EN -919. 54 pp.  
7 EFSA (European Food Safety Authority), 2017. Conclusion on the peer review of the pesticide risk 
assessment for the active substance terbuthylazine in light of con firmatory data submitted. EFSA 
Journal 2017;15(6):4868, 20 pp. https://doi.org/10.2903/j.efsa.2017.4868  
8 EFSA (European Food Safety Authority), 2019. Conclusion on the updated peer review of the pesticide 
risk assessment for the active substance terbuthylazine in light of conﬁrmatory data submitted. EFSA 
Journal 2019;17(9):5817, 21 pp. https://doi.org/10.2903/j.efsa.2019.5817  EN 3  EN (9) The draft assessment report, the addendum  to the draft assessment report  and the 
conclusions of the Authority were reviewed by the Member States and the 
Commission within the Standing Committee on Plants, Animals, Food and Feed and 
finalised on XX XXXX  2021 in the format of the updated  review report for 
terbut hylazine . 
(10) The applicant was given the possibility to submit comments on the updated review 
report.   
(11) The Commission has concluded that the additional information provided by the 
applicant is not sufficient to exclude a risk to consumers from exposure to met abolites 
of terbuthylazine whe re it is applied every year in the same field at a maximum rate of 
850 g/ha.  
(12) Therefore, it is necessary and appropriate to restrict the approval of terbuthylazine  to 
use only every third year on the same field at a maximum rat e of 850  g/ha. It is also 
necessary to amend the maximum levels of the relevant impurities propazine and 
simazine  that are permitted in the technical material as commercially manufactured .  
(13) Implementing Regulations (EU) No 820/2011 and (EU) No 540/2011 sho uld therefore 
be amended accordingly.  
(14) Member States should be provided with time to withdraw or amend authorisations for 
plant protection products containing terbuthylazine which do not comply  with the 
restricted conditions of approval.  
(15) For plant protectio n products containing terbuthylazine , where Member States grant 
any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, th at 
period should expire at the latest 12 months after the entry into force of this 
Regulation.  
(16) The measures pr ovided for in this Regulation  are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1 
Amendment to Implementing Regulation (EU) No 820/2011  
Annex I to Implementing Regulation (EU) No 820/2011  is amended in accordance with 
Annex I to this Regulation.  
Article 2 
Amendment to Implementing Regulation (EU) No 540/2011  
The Annex to Implementing Regulation (EU) No 540/2011 is amend ed in accordance wit h 
Annex  II to this Regulation.  
Article 3  
Transitional measures  
Member States shall, where necessary, withdraw or amend authorisations for plant protection 
products containing terbuthylazine  as an active substance by  … [Office of Publications please 
insert date 6 months from the date of entry into force ]. EN 4  EN Article 4  
Grace period  
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) 
No 1107/2009 shall be as short as possible and shall expire by  … [Office of Publications 
please insert date 12 months from the date of entry into force ]. 
Article 5 
Entry into force  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN