G/TBT/N/EU/554  
 
13 March 2018  
(18-1518) 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. 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): 
Pymetrozine (pesticide active substance)  
5. Title, number of pages and language(s) of the notified document: Draft 
Commission Implementing Regulation concerning the non -renewal of approval of the active 
substance pymetrozine, in accordance with Regulation (EC) No 1107/2009 of the European 
Parliament and of the Council concerning the placing of plant protection produc ts on the 
market, and amending 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 pymetrozine is not re newed in accordance with 
Regulation (EC)  No 1107/2009. Existing authorised plant protection products containing 
pymetrozine will be withdrawn from the market. The non -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 approved under 
Directive  91/414/EEC.  
This decision only concerns the placing on the market of this substance and does not affect 
the Maximum Residue Levels (MRLs) for residu es of the concerned pesticide. However, 
following non -approval, separate action may be taken on MRLs. Any subsequent action on 
MRLs will be subject to notification under the SPS procedure.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; protection of animal or plant life or 
health; protection of the environment.  
In order for an active substance to be approved in accordance with Regulation 
(EC) No 1107/2009 (concerning the pl acing 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) which must be  met to enable approval.  G/TBT/N/EU/554  
 
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  During the evaluation and peer -review of pymetrozine, 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).  
Specific concern s were identified as follows: there is a high potential for the representative 
uses assessed to result in groundwater exposure above the parametric drinking water limit 
of 0.1  μg/l by the toxicologically relevant metabolite CGA371075 in situations represen ted 
by all pertinent groundwater scenarios.  Moreover, s several other toxicologically relevant 
metabolites are also predicted to occur above 0.1 μg/L in some or all scenarios for the 
representative uses evaluated.    
Additionally, the scientific assessment f or potential endocrine disruption properties of 
pymetrozine could not be finalised. Nevertheless, pymetrozine is considered to have 
endocrine disrupting properties in accordance with the interim criteria in Regulation 
(EC) No 1107/2009.  
Furthermore, the toxicological profile of metabolites included in the plant residue definition 
for risk assessment could not be confirmed based on the information available and the risk 
to aquatic organisms from exposure to metabolite M3MF could not be ﬁnalised for all 
repres entatie uses considered based on the information submitted in the dossier.  
These concerns mean that pymetrozine does not meet the approval criteria as outlined in 
Regulation (EC) No 1107/2009 and cannot be approved currently.  
Existing authorisations will n eed to be withdrawn; Member States must withdraw existing 
plant protection products containing pymetrozine 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 sha ll expire at the latest 15 months from the entry into force.  
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 repeal ing 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  
 Conclusion on the peer review of the pesticide risk assessment of the active 
substance pymetrozine. EFSA Journal 2014;12(9):3817, 102 pp. 
doi:10.2903/j.efsa.2014.3817.  
https://www.efsa.euro pa.eu/en/efsajournal/pub/3817  
9. Proposed date of adoption:  June 2018  
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: Na tional 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/2018/TBT/EEC/18_1316_00_e.pdf