  
  
G/TBT/N/EU/699  
20 February 2020  
(20-1304) 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):  
Beta-cyfluthrin (pesticide acti ve 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 beta -cyfluthrin, in accordance with Regulation (EC) No 1107/2009 of t he 
European Parliament and of the Council concerning the placing of plant protection products 
on the market, and amending the Annex to Commission Implementing Regulation (EU) 
No 540/2011 (5 page(s), in English)  
6. Description of content:  This draft Commis sion Implementing Regulation provides that 
the approval of the active substance beta -cyfluthrin is not renewed in accordance with 
Regulation (EC)  No 1107/2009. EU Member States shall withdraw authorisations for plant 
protection products containing beta -cyfluthrin as active substance. The non -renewal of 
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 Directiv e 91/414/EEC.  
This decision only concerns the placing on the market of this substance and plant 
protection products containing it. Following non -approval and the expiry of all grace 
periods for stocks of products containing this substance, 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 o r 
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/699  
 
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  During the evaluation and peer -review of beta -cyfluthrin, a number of concerns and areas 
that could not be finalise d were identified. These are detailed in the conclusion of the 
European Food Safety Authority (EFSA).  
EFSA identfied concerns. In particular, EFSA identified an unacceptable risk to workers 
loading and sowing the beet seeds treated withbeta -cyfluthrin. In  addition, for cases of 
potato and wheat field applications of beta -cyfluthrin EFSA identified high risk to residents, 
to non -target arthropods and to aquatic organisms. Furthermore, for the cases of use on 
tomatoes in greenhouses (permanent and non -perman ent), EFSA identified unacceptable 
risk to operators and workers and, in case of use on tomatoes in non -permanent 
greenhouses, to non -target arthropods. In addition, the consumer assessment could not be 
finalised based on the available data.  
These concern s mean that beta -cyfluthrin does not meet the approval criteria as outlined 
in 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 produ cts containing beta -cyfluthrinat 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 f inal 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  
•  Conclusion on the peer review of the pesticide risk assessment of the active 
substance beta -cyfluthrin. The EFSA Conclusions regarding the pe er review of the 
pesticide risk assessment of beta -cyfluthrin (EFSA Journal 2018;16(9):5405) 
https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5405  
9. Proposed date of adoption:  3rd quarter 2020.  
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/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2020/TBT/EEC/20_1307_00_e.pdf  
 