G/TBT/N/EU/497  
 
4 August 2017  
(17-4224) Page: 1/2 
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 Commission,  
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/   
3. Notified und er 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):  Clothianidin (pesticide 
active substance)  
5. Title, number of pages  and language(s)  of the notified document:  Draft Commission 
Implementing Regulation amending Implementing Regulation (EU) No 540/2011 as 
regards the conditions of approval of the active substance clothianidin (5 pages + Annex 
2 pages, in English)   
6. Description of content:  This draft Commission Implementing Regulation provides that 
the conditions of approval of the active substance clothianidin are amended. Existing 
authorisations for plant protection products containing clothianidin will be amended or 
withdrawn from the market. The amendment is based on the evaluation of confirmatory 
information submitted following the amendment of the conditions of approval of 
clothianidin (Regulation (EU) No 485/2013).  
This decision concerns the pl acing on the market of this substance and does not affect the 
Maximum Residue Levels (MRLs) for residues of the concerned pesticide.  
7. Objective and rationale , including the nature of urgent problems where applicable: 
During the evaluation of the confir matory data on clothianidin, provided following the 
amendment of its conditions of approval (Regulation (EU) No 485/2013), for most crops, 
high acute risks for bees were identified from plant protection products containing the 
active substance clothianidin . In particular, as regards exposure via dust, high acute risks 
for bees were identified for winter cereals and high chronic risks to bees cannot be 
excluded for sugar beets.  For the consumption of residues in contaminated pollen and 
nectar, high acute and  chronic risks were identified or a high risk cannot be excluded for 
most field uses.  Chronic and acute risks to bees were also identified in the succeeding 
crops for all field uses. For forestry nursery, no data was provided by the applicants and 
risks to  bees can therefore not be excluded.  G/TBT/N/EU/497  
 
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  In order to ensure the protection of bees, it is necessary to amend the approval conditions 
to include a further restriction of use. In particular, the use of clothianidin should be 
limited to permanent greenhouses wher e the crop stays its entire life cycle within the 
greenhouse and is thus not replanted outside.  
Seeds treated with plant protection products containing clothianidin may not be placed on 
the market or used, with the exception of seeds to be used in permanen t greenhouses 
where the crop stays its entire life cycle within the greenhouse and is thus not replanted 
outside.  
Existing authorisations will need to be amended or withdrawn; Member States must amend 
or withdraw existing authorisations for plant protectio n products containing clothianidin at 
the latest by 3 months from the date of entry into force. A period of grace in line with 
Article 46 of Regulation 1107/2009 is allowed for and shall expire at the latest 6 months from 
the entry into force.  
8. Relevan t documents:   
Regulation (EC) No 1107/2009 of the European Parl iament 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/EEC:  
http://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:32009R1107&qid=1437730988988&from=EN  
Commission Implementing Regulation (EU) No  540/2011 of 25  May 201 1 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) 
http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1442928512004&uri=CELEX:32011R0540  
Commission Implementing Regulation (EU) No 485/2013 of 24 May 2013 amending 
Implementing Regulation (EU) No 540/2011, as regards the conditions of appro val of the 
active substances clothianidin, thiamethoxam and imidacloprid, and prohibiting the use 
and sale of seeds treated with plant protection products containing those active substances 
(OJ L 139, 25.5.2013, p. 238 –252) 
http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1491312449480&uri=CELEX:32013R0485  
EFSA (European Food Safety Authority), 2016. Peer review of the pesticide risk 
assessment for the ac tive substance clothianidin in light of confirmatory data submitted. 
EFSA Journal 2016;14(11):4606 [34 pp.].  
http://www.efsa.europa.eu/en/efsajournal/pub/4606   
9. Proposed date of adoption:  4th quarter 2017  
Proposed date of entry into force:  20 days following publication in the OJ  
10. Final date for comments:  60 days from notification  
11. Texts available from : National enquiry point  [ ] or address, telephone and fax 
number s and e mail and website address es, 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 Website: http://ec.europa.eu/growth/tools -databases/tbt/  
https://members.wto.org/crnattachments/2017/TBT/EEC/17_3483 _00_e.pdf  
https://members.wto.org/crnattachments/2017/TBT/EEC/17_3483_01_e.pdf