G/TBT/N/EU/825  
29 July 2021  
(21-5930) 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 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/e n/  
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):  
Cypermethrin (pesticide active substance); Pesticides and other agrochemicals (ICS 
65.100)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regulation renewing the approval of the active substance 
cypermet hrin as a candidate for substitution 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 amending the Annex to Commission 
Implementing Regulati on (EU) No 540/2011 (5 page(s), in English; 5 page(s), in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance cypermethrin is renewed in accordance with 
Regulation (EC)  No 1107/2009. It is however, necessary to include certain conditions and 
restrictions for spray applications outdoors to ensure the required protection level for 
aquatic organisms and non -targeted arthropods including bees are possible.  
Existing authorised plan t protection products containing cypermethrin will be reviewed in 
accordance with the conditions and restrictions set in this act. The conditions and 
restrictions are 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 substanceand  does not 
affect  the Maximum Residue Levels (MRLs) for residues of the concerned active 
substance. Any action on  MRLs will be subject to notification under the SPS procedure.  
7. Objective and rationale, including the nature of urgent problems where 
applic able:  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 G/TBT/N/EU/825  
 
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  the market), it must be demonstrated that the substance is not harmful to human health, 
animal hea lth or the environment. Criteria are listed in Article 4 of the Regulation (and 
also detailed in Annex  II thereto) which must be met to enable approval. During the 
evaluation and peer -review of cypermethrin, 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). In its Statement on risk mitigation measures on cypermethrin 
published on 4 October 2019, EFSA presented the levels of the necessary drift reduct ion 
and the measures that would be needed to demonstrate low risk to the non -target 
organisms, in particular aquatic organisms and non -target arthropods, including bees. 
This means that cypermethrin meets the approval criteria as outlined in Regulation (EC ) 
No 1107/2009 only if appropriate mitigation measures to ensure the required protection 
level for aquatic organisms, non -targeted arthropods including bees are put in place for 
spray applications outdoors. Existing authorisations will need to be amended o r withdrawn 
following renewal of authorisation in accordance with Article 43 of Regulation (EC) No 
1107/2009.; Protection of human health or safety; Protection of animal or plant life or 
health; Protection of the environment  
8. Relevant documents:   
Regula tion (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 
cypermethrin: EFSA Journal 2018;16(8):5402. Conclusion on the peer review of the 
pesticide risk assessment of the active substance cypermethrin. Available online: 
www.efsa.europa.eu  
EFSA Statement on risk mitigation measures on cypermethrin 
https://www.efsa.europa.eu/en/efsajournal/pub/5822 . 
9. Proposed date of adoption:  4th quarter 2021  
Proposed date of entry into force:  20 days fo llowing 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/2021/TBT/EEC/21_4962_00_e.pdf  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_4962_01_e.pdf