G/TBT/N/EU/499  
 
4 August 2017  
(17-4226) 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/en/   
3. Notifi ed 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):  Thiamethoxam 
(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 thiamethoxam (5 pages + 
Annex 2 p ages, in English)   
6. Description of content:  This draft Commission Implementing Regulation provides that 
the conditions of approval of the active substance thiamethoxam are amended. Existing 
authorisations for plant protection products containing thiamet hoxam 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withdrawn from the market.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 
thiamethoxam (Regulation (EU) No 485/2013).  
This decision concerns the placing 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: 
Protection of animal or plant  life or health; Protection of the environment; During the 
evaluation of the confirmatory data on thiamethoxam, provided following the amendment 
of its conditions of approval (Regulation (EU) No 485/2013), the submitted additional 
information was considere d not sufficient in view of the requirements set in Regulation 
(EU) No 485/2013 and therefore an unacceptable risk to bees and other pollinators cannot 
be excluded unless further restrictions would be provided.  
In order to ensure the protection of bees, i t is necessary to amend the approval conditions 
to include a further restriction of use. In particular, the use of thiamethoxam should be 
limited to permanent greenhouses where the crop stays its entire life cycle within the 
greenhouse and is thus not repl anted outside.  G/TBT/N/EU/499  
 
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  Seeds treated with plant protection products containing thiamethoxam may not be placed 
on the market or used, with the exception of seeds to be used in permanent greenhouses 
where the crop stays its entire life cycle within the greenhouse an d is thus not replanted 
outside.  
Existing authorisations will need to be amended or withdrawn; Member States must amend 
or withdraw existing authorisations for plant protection products containing thiamethoxam 
at the latest by 3 months from the date of ent ry 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. Relevant documents:   
Regulation (EC) No 1107/2009 of the European Parliament and o f 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 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) 
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 approval of the 
active substances clothianidin, thiamethoxam and imidacloprid, and pro hibiting 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. Outcome of the consultation with Member 
States, the applicant and EFSA on the pesticide risk assessment for thiamethoxam in light 
of con firmatory data. EFSA Supporting publication 2016:EN -1020 
http://www.efsa.europa.eu/en/supporting/pub/1020e   
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 EU -TBT Website : http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2017/TBT/EEC/17_3485_00_e.pdf  
https://members.wto.org/crnattachments/2017/TBT/EEC/17_3485_01_e.pdf