G/TBT/N/EU/774  
22 January 2021  
(21-0671) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  EUROPEAN UNION   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  European Commission  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
European Comm ission  
EU-TBT Enquiry Point  
Fax: +(32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/e n/  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Terbuthylazine (pesticide active substance); Pesticides and other agrochemicals 
(ICS 65.100)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regulation amending Implementing Regulations (EU) 
No 540/2011 a nd 820/2011 as regards the conditions of approval of the active substance 
terbuthylazine (5 page(s), in English; 5 page(s), in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active subst ance terbuthylazine is amended to set revised limits for 
two toxicologically relevant impurities in the technical material and to introduce a 
restriction to the rate and frequency of use of the substance. EU Member States shall 
review authorisations for pl ant protection products containing terbuthylazine as an active 
substance. The amendment of the conditions of approval is based on the evaluation of 
the confirmatory information required in the approval of terbuthylazine for use as a 
pesticide active substa nce in the EU under Regulation (EC) No 1107/2009.  
This decision only concerns the placing on the market of this substance and plant 
protection products containing it.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  In order for an active substance to be approved in accordance with 
Regulation (EC)  No 1107/2009 (concerning the placing of plant protection products on 
the market), it must be demonstrated that the substance is not harmful to human health, 
animal health or the environment. Criteria are listed in Article 4 of the Regulation (and 
also detailed in Annex  II thereto) which must be met to enable approval. Based on the 
assessment of the confirmatory information related to the specification of the techn ical 
material as manufactured, it is concluded that revised maximum levels for propazine and G/TBT/N/EU/774  
 
- 2 - 
 
  simazine in the technical material as manufactured should be established. EFSA also 
identified a risk to infants and toddlers under some conditions of use from exp osure to 
metabolites of terbuthylazine through food and drinking water, according to the additional 
information provided by the applicant and based on the use of terbuthylazine at a rate of 
850 g/ha each year on the same field. Furthermore, where terbuthyl azine 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 derived based on the available data. 
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 rate of 8 50 g/ha. It is also necessary 
to amend the maximum levels of the relevant impurities propazine and simazine (to a 
maximum of 9 g/kg). Existing authorisations will need to be adapted accordingly; EU 
Member States must ensure that the placing on the market o f terbuthylazine and the 
plant protection products containing it are in compliance with the amended conditions of 
approval as introduced by this draft Commission Implementing Regulation; Protection of 
human health or safety; Protection of animal or plant l ife or health; Protection of the 
environment  
8. Relevant documents:   
• 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 Dire ctives 79/117/EEC and 91/414/EEC: 
https://eur -lex.europa.eu/legal -
content/AUTO/?uri=CELEX:32009R1107&qid=1590756186915&rid=1  
• Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 
implementing Regulation (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 –186) https://eur -lex.europa.eu/legal -
content/AUTO/?uri=CELEX:32011R0540&qid=1590756246146&rid=1  
• 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   https://eur -lex.europa .eu/legal -
content/EN/TXT/PDF/?uri=CELEX:32011R0820&from=EN   
• EFSA (European Food Safety Authority), 2016. Technical report on the outcome 
of the consultation with Member States, the applicant and EFSA on the pesticide 
risk assessment for terbuthylazine in l ight of confirmatory data. EFSA supporting 
publication 2016:EN -919. 54 pp. 
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2016.EN -919 
• EFSA (European Fo od 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://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5817c   
9. Proposed date of adoption:  Second quarter 2021  
Proposed date of entry into force:  20 days following publication in the Official Jour nal 
of the EU  
10. Final date for comments:  60 days from notification  G/TBT/N/EU/774  
 
- 3 - 
 
  11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
European Commission  
EU-TBT Enquiry Point  
Fax: + (32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu  
The text is available on the EU -TBT Website: http://ec.europa.e u/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_0624_00_e.pdf  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_0624_01_e.pdf