G/TBT/N/EU/908  
6 July 2022  
(22-5221) 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/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CC CN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Clothianidin and thiamethoxam (pesticide active substances)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commi ssion Regulation amending Annexes II and V to Regulation (EC) No 396/2005 of 
the European Parliament and of the Council as regards maximum residue levels for 
clothianidin and thiamethoxam in or on certain products; (7 page(s), in English), (1 
page(s), in E nglish), (13 page(s), in English)  
6. Description of content:  The proposed draft Regulation addresses an environmental 
concern of global nature, that it is the decline of pollinators worldwide. It concerns the 
review of all existing maximum residue levels (MRLs) for clothianidin and thiamethoxam 
to the limit of quantification in accordance with Regulation (EC) No 396/2005. This draft 
Regulation follows the non -renewal of the approval, due to the withdrawal of all 
applications for renewal, and expiry of all grace periods provided by Member States for 
stocks of plant protection products (PPP) on 31 January 2019 for clothianidin and on 30 
April 2019 for thiamethoxam. Prior to the non -renewal of approval, the outdoor uses of 
clothianidin and thiamethoxam were al ready severely restricted in 2013 (Regulation (EU) 
No 485/2013) and completely banned in 2018 (Regulation (EU) 2018/784 and Regulation 
(EU) 2018/785) following the risk assessments performed by European Food Safety 
Authority concluding that due to their in trinsic properties, the exposure from outdoor use 
of clothianidin and thiamethoxam leads to unacceptable risks for bees, or such risks could 
not be excluded based on the available data.  
Such measures were previously notified to the World Trade Organization through the 
notifications G/TBT/N/EU/497, G/TBT/N/EU/499 and G/SPS/N/EU/39  G/TBT/N/EU/908  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Clothianidin and thiamethoxam were included in Annex I to Directive 
91/414/EEC on  1 August 2006 and 1 February 2007, respectively, and, therefore, before 
the entry into force of Regulation (EU) No 1107/2009. The most recent risk assessments 
for bees from the exposure to these substances conducted by the Authority under 
Regulation (EC) No 1107/2009 found that, due to their intrinsic properties, the exposure 
from outdoor use of clothianidin and thiamethoxam leads to unacceptable risks for bees, 
or such risks could not be excluded based on the available data. Therefore, Commission 
Implemen ting Regulations (EU) 2018/784 and 2018/785 restricted the approval of 
clothianidin and thiamethoxam, respectively, to uses in permanent greenhouses only and 
required that the resulting crops stayed within a permanent greenhouse during their 
entire life cy cle. Following the adoption of these restrictions, all applications for the 
renewal of the approval of the active substances clothianidin and thiamethoxam were 
withdrawn.  
Adverse effects of clothianidin and thiamethoxam on bees are directly linked to the 
intrinsic properties of those substances. Therefore, the risks for bees from outdoor uses 
of these substances are unlikely to be limited to the European Union. Given the global 
nature of pollinator decline, there is a need to ensure that also commodities im ported into 
the European Union do not contain residues resulting from good agricultural practices 
based on outdoor uses of clothianidin and/or thiamethoxam, in order to avoid the transfer 
of adverse effects on bees from food production in the European Unio n to production of 
food in other parts of the world that is then imported into the European Union.  
The MRLs for clothianidin and thiamethoxam were set in Annex II to Regulation (EC) No 
396/2005, including some MRLs which were based on Codex maximum residue  limits 
(CXLs). All authorisations for plant protection products containing clothianidin and/or 
thiamethoxam in the European Union have been revoked. It is therefore appropriate to 
delete the MRLs based in obsoleted EU uses and CXLs currently set out in An nex II of 
Regulation (EC) No 396/2005.  
A reasonable period would be allowed to elapse before the modified MRLs become 
applicable in order to permit operators in third countries, especially in least developed 
and developing countries, and food business oper ators to prepare themselves to meet the 
new requirements which will result from the modification of the MRLs. Such adaptation 
can be reasonably expected to be achieved after three growing seasons in both 
hemispheres (equivalent to 36 months); Protection of  animal or plant life or health; 
Protection of the environment  
8. Relevant documents:   
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 
2002 laying down the general principles and requirements of food law, establishing the 
European Food Safety Authority and laying down procedures in matters of food safe ty. OJ 
L 31, 1.2.2002, p. 1  
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/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  
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 
February 2005 on maximum residue levels of pesticides in or  on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC (OJ L 070 16.3.2005, p. 
1) 
EUR-Lex - 02005R0396 -20220516 - EN - EUR-Lex (europa.eu)  G/TBT/N/EU/908  
 
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  Commission Implementing Regulation (EU) 2018/784 of 29 May 2018 amending 
Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the 
active substance clothianidin (OJ L 132, 30.5.2018, p. 35).  
Commission Implementing Re gulation (EU) 2018/785 of 29 May 2018 amending 
Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the 
active substance thiamethoxam (OJ L 132, 30.5.2018, p. 40).  
EFSA (European Food Safety Authority), 2014. Reasoned opinion o n the review of the 
existing maximum residue levels (MRLs) for clothianidin and thiamethoxam according to 
Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2014;12(12):3918, 120 pp. 
doi:10.2903/j.efsa.2014.3918 https://www.efsa.europa.eu/en/efsajournal/pub/3918  
European Food Safety Authority; Peer review of the pesticide risk assessment for bees for 
the active substance clothianidin considering the uses as seed treatments and granules.  
EFSA Journal 2018;16(2):5177. https://www.efsa.europa.eu/en/efsajournal/pub/5179  
European Food Safety Authority; Peer review of the pesticide risk assessment for bees for 
the a ctive substance thiamethoxam considering the uses as seed treatments and 
granules. EFSA Journal 2018;16(2):5179. 
https://www.efsa.europa.eu/en/efsajournal/pub/5179  
Relevant international st andards :  
· Codex Maximum Residue Limits for clothianidin (238): https://www.fao.org/fao -who-
codexalimentarius/codex -texts/dbs/pestres/pesticide -detail/en/?p_id=238  
· Codex Maximum Residue Limits for clothia nidin (245): https://www.fao.org/fao -who-
codexalimentarius/codex -texts/dbs/pestres/pesticide -detail/en/?p_id=245  
Additional information for comparison purposes - old and new values of clothianidin and 
thiamethoxam (see Section 11 below).  
9. Proposed date of adoption:  2nd quarter 2023.  
Proposed date of entry into force:  20 days following publication in the Official Journal 
of the EU  
10. Final date for comments:  60 days from notification  
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.eu/growt h/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2022/TBT/EEC/22_4547_00_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/EEC/22_4547_01_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/EEC/22_4547_02_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/EEC/22_4547_03_e.pdf