G/SPS/N/EU/662  
21 July 2023  
(23-4992) 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):  Clofentezine (pesticide 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 concerning 
the non -renewal of approval of the active substance clofentezine, in accordance with 
Regulati on (EC) No 1107/2009 of the European Parliament and of the Council and 
amending Commission Implementing Regulation (EU) No 540/2011 . Language(s):  
English . Number of pages:  5 
https://members.wto.org/crnattachments/2023/SPS/EEC/23_11175_00_e.pdf  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance clofentezine is not renewed in accordance with 
Regulation (EC) No 1107/2009. Member States shall withdraw authorisations for plant 
protection products containi ng clofentezine as an active substance. The non -renewal of 
approval is based on the first evaluation of the substance for use as a pesticide active 
substance in the European Union under Regulation (EC) No 1107/2009. The substance was 
formerly assessed and approved under Directive 91/414/ EEC.  
This decision only concerns the placing on 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 sub stance, separate action may be taken on 
MRLs and a separate notification 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/994  
7. Objective and rati onale: [X]  food safety, [X]  animal health, [X]  plant protection, 
[ ] 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) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  G/SPS/N/EU/662  
 
- 2 - 
 
  [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 stand ard:  
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 1 53, 11 June 2011, 
p. 1–186) 
http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1442928512004&uri=CELEX:32011R0540  
− Commis sion Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to 
Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of 
endocrine disrupting properties ( OJ L 101, 20 April 2018, p. 33)  
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A32018R0605  
− Regulation (EC) No 396/2005 of the European Parliament and of the Council of 
23 February 2005 on m aximum residue levels of pesticides in or on food and feed of 
plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 
16 March 2005, p. 1)  
https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=celex%3A32005R0396  
− EFSA (European Food Safety Authority), Alvarez F, Arena M, Auteri D, Borroto 
J,Brancato A, Carrasco Cabrera L, Castoldi AF, Chiusolo A, Colagiorgi A, Colas M, 
Crivellente F, DeLentdecker C, Egsmose M, Fait G, Gouliarmou V, Ferilli F, Greco L, 
Ippolito A, Istace F, Jarrah S,Kardassi D, Kienzler A, Leuschner R, Lava R, Linguadoca 
A, Lythgo C, Magrans O, Mangas I, Miron I,Molnar T, Padovani L, Parra Morte JM, 
Pedersen  R, Reich H, Santos M, Sharp R, Szentes C, Terron A,Tiramani M, Vagenende 
B and Villamar -Bouza L, 2021. Conclusion on the peer review of the pesticiderisk 
assessment of the active substance clofentezine. EFSA Journal 2021;19(8):6817, 
35 pp. 
https://doi.org/10.2903/j.efsa.2021.6817  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : 4th quarter 2023.  
Proposed date of publication (dd/mm/yy) : 4th quarter 2023.  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : Three days following publication in the Official Journal of the 
European  Union.  
[ ] Trade facilit ating 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/994.  
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/662  
 
- 3 - 
 
  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