G/TBT/N/EU/994  
14 July 2023  
(23-4753) Page: 1/3 
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/tbt/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CC CN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Clofentezine (pesticide active substance)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing  Regulation concerning the non -renewal of approval of the 
active substance clofentezine, in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council and amending Commission Implementing 
Regulation (EU) No 540/2011; (5 page (s), in English)  
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 authoris ations for plant 
protection products containing 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 EU under Regulation (EC) No 1107/2009. The sub stance 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 substance, separate action may be taken 
on MRLs and a separate notification will be made in accordance with SPS procedures.  G/TBT/N/EU/994  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:   
In order for 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 
environment. 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 clofentezine, a number of concerns and areas 
that could not be finalised were  identified. These are detailed in the conclusion of the 
European Food Safety Authority (EFSA).  
In particular, based on the available information submitted in the dossier, clofentezine 
has endocrine disrupting properties that may cause adverse effects in h umans, as set out 
in point 3.6.5 of Annex II to Regulation (EC) No 1107/2009. Negligible exposure cannot 
be demonstrated for clofentezine since residues above the default value set in accordance 
with point (b) of Article 18(1) of Regulation (EC) No 396/200 5 may be expected to occur. 
Therefore, the requirement set out in point 3.6.5 of Annex II to Regulation (EC) No 
1107/2009 is not fulfilled.  
Furthermore, a high long -term risk to birds and wild mammals for the representative uses 
not grown in permanent gree nhouses was identified. The consumer risk assessment could 
not be performed and maximum residue levels cannot be proposed based on the available 
data. Finally, the risk assessment for non -target arthropods could also not be finalised for 
the representative  uses not grown in permanent greenhouses.  
Derogation in accordance with Article 4(7) to Regulation (EC) No 1107/2009 does not 
apply for the reasons set out in the draft Regulation.  
These concerns mean that clofentezine does not meet the approval criteria a s outlined in 
Regulation (EC) No 1107/2009 and cannot be approved currently.  
Existing authorisations will need to be withdrawn; Member States must withdraw existing 
plant protection products containing clofentezine at the latest by 6 months from the date 
of entry into force. A period of grace in line with Article 46 of Regulation 1107/2009 is 
allowed for and shall expire at the latest 12 months from the entry into force (allowing 
for a final season of use).  
Protection of human health or safety; Protec tion 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  
Commission 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 end ocrine 
disrupting properties ( OJ L 101, 20.4.2018, p. 33).  
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A32018R0605  
Regulation (EC) No 396/2005 of the Euro pean Parliament and of the Council of 23 
February 2005 on maximum 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, 16.3.2005, p. 
1). G/TBT/N/EU/994  
 
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  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, Col agiorgi 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, P arra 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  
9. Proposed date of adoption:  4th quarter 2023  
Proposed date of entry into force:  3 days following 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.e u/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_10999_00_e.pdf