G/TBT/N/EU/867  
24 January 2022  
(22-0537) 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/tb t/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):  Bifenazate  
(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 
bifenazate in accorda nce 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 (5 
page(s), in English; 4 p age(s), in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance bifenazate is renewed in accordance with Regulation 
(EC) No 1107/2009. It is however, necessary to include cert ain conditions and 
restrictions, i.e. to restrict the use of plant protection products containing bifenazate to 
non-edible crops in permanent greenhouses and to require further confirmatory 
information.  
Existing authorised plant protection products contain ing bifenazate 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) N o 1107/2009. The substance was formerly 
approved under Directive 91/414/EEC.  
This decision only concerns the placing on the market of this substance. Following 
restriction of the approval and the consequent expiry of all grace periods for stocks of 
products, separate legal action may be taken on Maximum Residue Levels and a separate 
notification will be made in accordance with SPS procedures in due time.  G/TBT/N/EU/867  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  In order f or 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 envir onment. 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 bifenazate, a number of concerns and areas that could not 
be finalised were id entified. These are detailed in the conclusion of the European Food 
Safety Authority (EFSA). This means that bifenazate meets the approval criteria as 
outlined in Regulation (EC) No  1107/2009 only if its use is restricted to non -edible crops 
in permanent g reenhouses. The restriction to use on non -edible crops will exclude dietary 
exposure of consumers and is required since the consumer risk assessment could not be 
finalised. As a high risk was identified to birds via long term exposure to bifenazate, a 
restriction to use in greenhouses as defined in Article 3 of Regulation (EC) No 1107/2009 
will ensure that birds are not exposed to bifenazate. Existing authorisations will need to 
be amended or withdrawn following renewal of authorisation in accordance with A rticle 
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:  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 
bifenazate EFSA Journal 2017;15(1):4693. EFSA Updated peer review of the pesticide 
risk assessment of the active substance bifenazate EFSA Journal 2021;19(8):6818 
Available online: www.efsa.europa.eu  
9. Proposed date of adoption:  2nd quarter 2022.  
Proposed date of entry into force:  20 days follo wing 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/2022/TBT/EEC/22_0730_00_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/EEC/22_0730_01_e.pdf