G/TBT/N/EU/997  
20 July 2023  
(23-4947) 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 CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addit ion, where applicable):  
Benthiavalicarb (pesticide active substance)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regulation concerning the non -renewal of the approval of the 
active substance Benthiaval icarb, 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 R egulation provides that 
the approval of the active substance Benthiavalicarb is not renewed in accordance with 
Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant 
protection products containing Benthiavalicarb as an activ e 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 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 substance, separate action will likely be  
taken on MRLs and a separate notification will be made in accordance with SPS 
procedures.  G/TBT/N/EU/997  
 
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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 als o detailed in Annex 
II thereto) which must be met to enable approval.  
During the evaluation and peer -review of Benthiavalicarb, a number of concerns and 
areas that could not be finalised were identified. These are detailed in the statement of 
the European Food Safety Authority (EFSA).  
The decision is based on a risk assessment carried out by a rapporteur EU Member State 
and peer reviewed by the European Food Safety Authority together with all EU Member 
States, taking into account other factors legi timate to the matter.  
In the case of Benthiavalicarb, the outcome of the risk assessment, as documented in the 
EFSA Conclusion, is not favourable and identifies critical areas of concern.  
These critical areas of concern have been identified:  
(1) Carcinogen ic potential. Criteria for classification as Category 1B are met (RAC opinion 
adopted on 18.03.2022);  
2) Criteria for endocrine disruption (ED) for humans for the T and EAS modalities are met. 
These concerns mean that Benthiavalicarb does not meet the appr oval criteria as outlined 
in Regulation (EC) No 1107/2009.  
Existing authorisations will need to be withdrawn; EU Member States must withdraw 
existing plant protection products containing Benthiavalicarb at the latest by 6 months 
from the date of entry into  force. A period of grace in line with Article 46 of Regulation 
(EC) No 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; Protection of an imal 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  
https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX:32009R1107  
Commission Imp lementing 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/EN/ALL/?uri=CELEX:32011R0540  
Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing 
Article 80(7) of Reg ulation (EC) No 1107/2009 of the European Parliament and of the 
Council concerning the placing of plant protection products on the market and establishing 
a list of candidates for substitution ( OJ L 67, 12.3.2015, p. 18 –22) 
https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX:32015R0408  
EFSA (European Food Safety Authority), 2022. Peer review of the pesticide risk 
assessment of the act ive substance benthiavalicarb.  
https://doi.org/10.2903/j.efsa.2021.6833  
9. Proposed date of adoption:  4th quarter 2023  
Proposed date of entry into force:  20 days following publication in the Official Journal 
of the EU  G/TBT/N/EU/997  
 
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  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.eu/growth/to ols-
databases/tbt/en/  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_11162_00_e.pdf