G/TBT/N/EU/770  
22 January 2021  
(21-0667) 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):  
Alpha -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 withdrawing the approval of the active substance 
alpha -cypermethrin 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 Commission Implementing Regulation (EU) No 540/2011 
(4 page(s), in En glish)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance alpha -cypermethrin is withdrawn in accordance with 
Regulation (EC)  No 1107/2009. EU Member States shall withdraw authorisati ons for plant 
protection products containing alpha -cypermethrin as an active substance.  
This decision only concerns the placing on the market of this substance and plant 
protection products containing it. Following withdrawal and the expiry of all grace p eriods 
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 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. Commission 
Implementing Regulation (EU) 2019/1690 renewed the approval of the active substa nce 
alpha -cypermethrin as candidate for substitution under the conditions that the applicant G/TBT/N/EU/770  
 
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  shall submit to the Commission, the EU Member States and the Authority confirmatory 
information as regards the toxicological profile of certain metabolites by 30  October  2020. 
In addition, confirmatory information had been required for three other points by other 
deadlines. On 14 October 2020, the applicant informed the Commission, the rapporteur 
Member State and EFSA that it would not submit any confirmatory data, therefore, as the 
information required in accordance with Article 6(f) was not submitted, the approval for 
alpha -cypermethrin has to be withdrawn according to Article 21(3) of Regulation (EC) 
No 1107/2009. Existing authorisations will need to be withdrawn;  EU Member States must 
withdraw existing plant protection products containing alpha -cypermethrin 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  
• Conclusion on the peer review of the pesticide risk assessment of the active 
substance alpha -cypermethrin.  
https://www.efsa.europa.eu/en/efsajournal/pub/5403  
• Commission Implementing Regulation (EU) 2019/1690 of 9 October 2019 
renewing the approval of the active substance alpha -cypermethrin, as a candidate 
for substit ution, 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 
Regulation (EU) No 540/2011  
https://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1570712208665&uri=CELEX:32019R1690  
9. Proposed date of adoption:  2nd quarter 2021  
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.w to.org/crnattachments/2021/TBT/EEC/21_0620_00_e.pdf