G/SPS/N/EU/565  
 
11 May 2022  
(22-3697) 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):  Pesticides  
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 penflufen and repeali ng Implementing Regulation (EU) 2018/185 
(Text  with EEA relevance) . Language(s):  English . Number of pages:  4+3 
https://members.wto.org/crnattachments/2022/SPS/EEC/22_3376_00_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_3376_01_e.pdf  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval conditions of the active substance penflufen are amended in accordance with 
Regulation (EC) No 1107/2009 based on the absence of submission of the confirmatory 
data as requested in Commission Implementing Regulation (EU) No 1031/2013 of 
24 October  2013, approving the active substance penflufen for use in the E uropean  Union. 
Existing authori zed plant protection products containing penflufen will be reviewed in 
accordance with the restriction set in this act.  
This decision only concerns the placing o n the market of this substance and plant 
protection products containing it. Following non -approval and the expiry of all grace 
periods for stocks of products containing this substance, separate action will likely be 
taken on MRLs and a separate notificatio n will be made in accordance with 
SPS procedures.  
This draft Commission Implementing Regulation was also notified under the 
TBT Agreement in notice G/TBT/N/EU/890.  
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.   
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) :  G/SPS/N/EU/565  
 
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  [ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international 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  
https://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  June 2011, p. 1–186) 
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A02011R0540 -
20220301&qid=1651582218896  
− Regulation (EC) No 1272/2008 of the European Parliament and of the Council, of 16 
December 2008, on classification, labelling and packaging  of substances and mixtures, 
amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending 
Regulation (EC) No 1907/2006 (OJ L 353, 31 December 2008, p. 1)  
https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A32008R1272&qid=1651597406251  
− EFSA (European Food Safety Authority), 6 October 2016. Conclusion on the peer 
review of the pesticide risk assessment of the active substance penflufen . EFSA Journal 
2016;14(11):4604  
https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2016.4604  
− Opinion of 15 October 2018 concerning 5 -fluoro -1,3-dimethyl -N-[2-(4-ethylpentan -2-
yl)phenyl] -1Hpyrazole -4-carboxamide;2' -[(RS) -1,3-dimethylbutyl] -5-fluoro -1,3-
dimethylpyrazole -4-carboxanilide; penflufen (CLH -O-0000001412 -86-233/F)  
https://echa.europa.eu/documents/10162/9cc30b92 -d86c-d75e-74b7-a92bad9e3379  
10. Proposed date of adoption (dd/mm/yy) : 3rd quarter 2022  
Proposed date of publication (dd/mm/yy) : 3rd quarter 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 European Union.  
[ ] Trade facilitatin g 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/8 90. 
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  G/SPS/N/EU/565  
 
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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 Co mmission  
EU-TBT Enquiry Point  
Fax: +(32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu