G/TBT/N/EU/469  
 
31 March 2017  
(17-1777) Page: 1/2 
Committee on Technical Barr iers 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/  
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-cypermethrin 
(pesticide active substance).  
5. Title, number of pages  and language(s)  of the notified document:  Draft Commission 
Implementing Regulation concerning the non -approval of the active substance beta -
cypermethrin, in accordance with Regulation (EC) No 1107/2009 of the European 
Parliament a nd of the Council concerning the placing of plant protection products on the 
market (4 pages, in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the active substance beta -cypermethrin is not approved in acco rdance with 
Regulation  1107/2009 and cannot be placed on the market in plant protection products in 
the EU. The substance is not currently authorized in plant protection products in the EU; 
the non -approval is based on the first evaluation of the substance  for use as a pesticide 
active substance in the EU under Regulation 1107/2009.  
This decision only concerns the placing on the market of this substance and does not affect 
the Maximum Residue Levels (MRLs) for residues of the concerned pesticide. However, 
following non -approval, separate action may be taken on MRLs, if necessary, and if so 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 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. Cr iteria are listed in Article 4 of the Regulation (and also detailed in 
Annex  II) which must be met to enable approval. Beta -cypermethrin, however, is subject 
to the approval conditions as laid down in Directive 91/414/EEC as it falls under the 
transitional  provisions as detailed in Article 80(1)(a) of Regulation 1107/2009. Therefore G/TBT/N/EU/469  
 
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  the conditions as laid down in Article 5 of Directive 91/414/EEC must be fulfilled before 
approval can be granted.  
During the evaluation and peer -review of the substance, a numb er of concerns and areas 
that could not be finalized were identified. These are detailed in the conclusion of the 
European Food Safety Authority (EFSA); importantly EFSA concluded that for the uses of 
beta-cypermethrin assessed there is a high risk to aqua tic organisms, bees and non -target 
arthropods. In addition, the risk assessment for soil and aquatic organisms and the 
exposure assessment for groundwater could not be finalized as insufficient information was 
provided in relation to the fate and behaviour  of the cyclopropyl ring moiety of beta -
cypermethrin. Furthermore, information on metabolism in livestock in order to confirm the 
residue definition for animal products and further information on the toxicity profile of 
metabolite PBA and its relevance for  consumer ris k assessment were not provided.  
These concerns mean that beta -cypermethrin does not meet the conditions for approval as 
outlined in Article 5 of Directive 91/414/EEC.  
8. Relevant documents:   
 Regulation (EC) No 1107/2009 of the European Parl iament 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  
 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant 
protection products on the market http://eur -lex.europa.eu/legal -
content/en/ALL/?uri=CELEX:31991L0414   
 Conclusion on the peer review of the pesticide risk assessment of the active 
substance beta -cypermethrin.  
 EFSA Journal 2014 ;12(6):3717, 90 pp. doi:10.2903/j.efsa.2014.3717 
http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2014.3717/epdf  
9. Proposed date of adoption: 3rd quarter 2017  
Proposed date  of entry into force: 20 days from publication in the Official Journal of the 
European Union  
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 w ebsite 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 Website: http://ec.europa.eu/growth/tools -databases/tbt/  
https://members.wto.org/crnattachments/2017/TBT/EEC/17_1597_ 00_e.pdf