G/SPS/N/EU/413  
 
18 September 2020  
(20-6297) Page: 1/3 
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):  Fenpyrazamine (pe sticide active substance)  
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 amending 
Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the 
active substance fenpyrazamine . Language(s):  English . Number of pages:  6 
https://members.wto.org/crnattachments/2020/SPS/EEC/20_5498_00_e.pdf  
https://members.wto.org/crnattachments/2020/SPS/EEC/20_5498_01_e.pdf  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance fenpyrazamine is amended in accordance with 
Regulation (EC) No 1107/2009. EU Member States shall review authorisations for plant 
protection products containing fenpyrazamine as an active substance, where relevant. 
The amend ment of the conditions of approval is based on the evaluation to clarify the 
technical specification proposed in the approval of fenpyrazamine for use as a pesticide 
active substance in the EU under Regulation (EC) No 1107/2009.  
This decision only concerns  the placing on the market of this substance and plant  
protection products containing it and does not affect the Maximum Residue Levels (MRLs) 
for residues of the concerned pesticide; the impurity was considered not to be new in the 
commercial produced bat ches. 
This draft Commission Implementing Regulation was also notified under the TBT 
Agreement in notice G/TBT/N/EU/TBT/735.  
7. Objective and rationale: [X]  food safety, [X]  animal health, [X]  plant protection, 
[X] protect humans from animal/plant pest or disease, [X]  protect territory 
from other damage from pests.   G/SPS/N/EU/413  
 
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  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 international st andard?  
[ ] 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:  
https://eur -lex.europa.eu/legal -
content/AUTO/?uri=CELEX:32009R1107&qid=1590756186915&rid=1  
− 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) 
https://eur -lex.europa.eu/legal -
content/AUTO/?uri=C ELEX:32011R0540&qid=1590756246146&rid=1  
− Outcome of the consultation on the pesticide risk assessment of confirmatory data 
for the active substance fenpyrazamine. EFSA Journal (2012) 10(1):2496. 
doi:10.2903/j.efsa.2012.2496.  
http://www.efsa.europa.eu/en/supporting/pub/en -630  
10. Proposed date of adoption (dd/mm/yy) : Fourth quarter 2020.  
Proposed date of publication (dd/mm/yy) : Fourth quarter 2020.  
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 to be addressed 
to the TBT Enquiry Point on notice G/TBT/N/EU/735.  
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: +(322) 299 8043  
E-mail: grow-eu-tbt@ec.europa.eu   G/SPS/N/EU/413  
 
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  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: +(322) 299 8043  
E-mail: grow-eu-tbt@ec.europa.eu