G/TBT/N/EU/672  
31 July 2019  
(19-5028) 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 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. 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):  Thiacloprid 
(pesticide active substance)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Re gulation concerning the non -renewal of the approval of the 
active substance thiacloprid, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protection 
products on the market, and am ending the Annex to Commission Implementing 
Regulation (EU) No 540/2011 (5 page(s), in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance thiacloprid is not renewed in accordance with 
Regulation (EC)  No 1107/2009. EU Member States shall withdraw authorisations for plant 
protection products conta ining thiacloprid as active substance. The non -renewal of the 
approval is based on the first evaluation of the substance for use as a pesticide active 
substance in the EU under Regulation (EC) No 1107/2009. The substance was formerly 
assessed and approved under Directive  91/414/ EEC.  
This decision only concerns the placing on the market of this substance and plant 
protection products containing it. Following non -renewal of approval and the expiry of all 
grace periods for stocks of products containing this s ubstance, separate action will likely 
be taken on MRLs and a separate notification will be made in accordance with SPS 
procedures.  
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 G/TBT/N/EU/672  
 
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  also detailed in Annex  II) which must be met to enable approval. During the evaluation 
and peer -review of thiacloprid, a number of concerns and areas that could not be finalised 
were identified. These are detailed in the  conclusion of the European Food Safety 
Authority (EFSA). EFSA identified acritical concern in relation to the contamination of 
groundwater by metabolites of thiacloprid. In particular, metabolites M30, M34 and M46 
are predicted to occur above the parametr ic drinking water limit of 0,1  μg/L in all pertinent 
scenarios for all proposed uses of thiacloprid. These metabolites are considered a priori  
of concern since it cannot be excluded that they share the same carcinogenic properties 
of the parent active subs tance thiacloprid, which is clasified in accordance with Regulation 
(EC) No  1272/2008 of the European Parliament and of the Council as carcinogenic 
category 2. Therefore, it cannot currently be established that the presence of metabolites 
of thiacloprid in  groundwater will not result in unacceptable effects on groundwater and 
in harmful effects on human health. Furthermore, issues were raised as regards the 
consumer risk assessment and the risk assessment for birds and mammals (from the 
relevant plant metab olites on maize), aquatic organisms, bees and terrestrial non -target 
plants was not finalised. Additionally, thiacloprid is classified in accordance with 
Regulation (EC) No  1272/2008   also as toxic for reproduction category  1B. The applicant 
provided infor mation attempting to demonstrate that exposure of humans to thiacloprid 
can be considered negligible. The Authority presented the outcome of the assessment of 
that informaiton in its conclusion. Nevertheless, given the concerns identified (as outlined 
in recital 9 of the draft Implementing Regulation), a conclusion on whether exposure to 
humans is negligible for the purposes of point 3.6.4 of Annex II to Regulation (EC) 
No 1107/2009, is not necessary for the decision on whether the approval of thiacloprid 
can be renewed. These concerns mean that thiacloprid does not meet the approval criteria 
as outlined in Article 4 of Regulation (EC) No 1107/2009 and cannot be approved 
currently. Existing authorisations will need to be withdrawn; EU Member States must 
withdraw existing plant protection products containing thiacloprid at the latest by 
6 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 12 months from the 
entry into force (allowing for a final season of use).; Protection of human health or safety; 
Protection of animal or plant life 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 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 1272/2008 of the European Parliament and of the Cou ncil 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). 
https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX%3A32008R1272   
• Conclusion on the peer review of the pesticide risk assessment of the active 
substance thiacloprid. EFSA Journal 2019;17(3):5595. DOI: 
10.2903/j.efsa.2019.5595  
http://www.efsa.europa.eu/en/efsajournal/pub/5595  
9. Proposed date of adoption:  4th quarter 2019  
Proposed date of entry into force:  20 days following publication in the Official Journal 
of the EU  G/TBT/N/EU/672  
 
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  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/growth/tools -databases/tbt/en/  
https://members. wto.org/crnattachments/2019/TBT/EEC/19_4261_00_e.pdf