G/TBT/N/EU/961  
17 March 2023  
(23-1966) 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):  
Dimoxystrobin (pesticide active substance)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementin g Regulation concerning the non -renewal of the approval of the 
active substance dimoxystrobin, 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 a nd Commission Implementing Regulation (EU) 2015/408; 
(5 page(s), in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance dimoxystrobin is not renewed in accordance with 
Regula tion (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant 
protection products containing dimoxystrobin as an active substance. The non -renewal of 
approval is based on the first evaluation of the substance for use as a pesticide activ e 
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.  
7. Objecti ve and rationale, including the nature of urgent problems where 
applicable:   G/TBT/N/EU/961  
 
- 2 - 
 
  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 dem onstrated 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 dimoxystrobin, 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).  
High potential for groundwater contamination by groundwater relevant metab olites 
505M08 and 505M09 was identified in geoclimatic conditions represented by all the 
relevant FOCUS groundwater scenarios for all the representative uses assessed and 
therefore the requirements of point 3.10 of Annex II to Regulation (EC) No 1107/2009 
are not fulfilled.  
In particular, dimoxystrobin has a harmonised classification according to Regulation (EC) 
No 1272/2008 as Carcinogenic Category 2, H351 ("Suspected of causing cancer") and 
Toxic for Reproduction Category 2, H361d ("Suspected of damaging the unborn child"). 
Although metabolites 505M08 and 505M09 are unlikely to be genotoxic and available data 
demonstrate that those metabolites do not share the carcinogenic properties of the parent 
compound, no data are available for these metabolites as re gards their potential 
reproductive toxicity properties and therefore it is considered that they share the 
properties of the parent compound. Consequently, 505M08 and 505M09 are considered 
as toxicologically relevant groundwater metabolites.  
An additional i ssue, are high acute risks identified for aquatic invertebrates for 5 out of 6 
FOCUS scenarios for the representative use on winter oilseed rape and all FOCUS 
scenarios for the representative use on sunflower, also when considering mitigation 
measures that  reduce exposure (20 m no -spray buffer zone + 20 m vegetated filter strip). 
This by itself would, however, not lead to the conclusion that dimoxystrobin does not 
satisfy the approval criteria.  
Furthermore, the EFSA Statement noted that the risk assessment to honeybee larvae 
could not be finalised.  
These concerns mean that dimoxystrobin does not meet the approval 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 dimoxystrobin 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 entr y into 
force (allowing for a final season of use).  
Protection of human health or safety; Protection 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  
https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX:32009R1107  
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 substanc es (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 o n implementing 
Article 80(7) of Regulation (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  G/TBT/N/EU/961  
 
- 3 - 
 
  EFSA (European Food Safety Authority), 2022. Statement concerning the assessment of 
environmental f ate and behaviour and ecotoxicology in the context of the pesticides peer 
review of the active substance dimoxystrobin. EFSA Journal 2022; 20(11): e07634  
https://doi.org/10.2903/j.efsa.2022.7634  
9. Proposed date of adoption:  3rd quarter 2023  
Proposed date of entry into force:  20 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 te xt is available on the EU -TBT Website : http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_2090_00_e.pdf