G/SPS/N/EU/542  
28 January 2022  
(22-0721) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Bifenazate (pesti cide active substance); Pesticides and other 
agrochemicals (ICS code: 65.100)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Commission Implementing Regulation renewing 
the approval of the active substance bifenazate in accordance with Regulation (EC) No 
1107/2009 of the European Parliament and of the Council concerning the placing of plant 
protection pr oducts on the market, and amending the Annex to Commission Implementing 
Regulation (EU) No 540/2011  (Text with EEA relevance) . Language(s):  English . Number 
of pages:  5 and 4 
https://members.wto.org/crnattachments/2022/SPS/EEC/22_1044_00_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_1044_01_e.pdf  
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 certain 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 containing bifenazate will be reviewed in 
accordance with the conditions and restrictions set in this act. The conditio ns 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 pla cing 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 acc ordance with SPS procedures in due time.  
This draft Commission Regulation was also notified under the TBT Agreement in notice 
G/TBT/N/EU/867.  
7. Objective and rationale: [X]  food safety, [X]  animal health, [X]  plant protection, 
[X] protect humans from ani mal/plant pest or disease, [X]  protect territory from 
other damage from pests.   G/SPS/N/EU/542  
 
- 2 - 
 
  8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant inte rnational standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:  
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 p eer review of the pesticide risk 
assessment of the active substance bifenazate EFSA Journal 2021;19(8):6818 , available 
online: www.efsa.europa.eu   
10. Proposed date of adoption (dd/mm/yy) : Second quarter of 2022.  
Proposed date of publication (dd/mm/yy) : Second quarter of 2022.  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 20 days following publication in the Official Journal of the EU.  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable. Comments are only welcomed on TBT 
related issues and to be addressed to the TBT Enquiry Point on notice G/TBT/N/EU/867.  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (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  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (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