G/TBT/N/EU/1049  
27 February 2024  
(24-1793) Page: 1/2 
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):  
metconazole (pesticide active substance)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regulation renewing the approval of the active substance 
metconazole as a candidate for subs titution 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; (6 page(s), in English), (5 page(s), in 
English)  
6. Description of content:  This draf t Commission Implementing Regulation provides that 
the approval of the active substance metconazole is renewed in accordance with 
Regulation (EC) No 1107/2009. It is, however, necessary to include certain conditions 
and restrictions including in particular  a restriction to use only by professional users.  
Existing authorised plant protection products containing metconazole will be reviewed in 
accordance with the conditions and restrictions set in this act. The outcome of the 
assessment 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 
approved under Directive 91/414/EEC.  
This decision only concerns the placing on the market of this substance and does not 
affect the Maximum Residue Levels (MRLs) for residues of the concerned active 
substance. Any action on MRLs will be subject to notification under the SPS procedure.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  In order for an active substance to be approved in accordance with G/TBT/N/EU/1049  
 
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  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 metconazole, a number of concerns and areas 
that cou ld not be finalised were identified, and experts considered the potential link 
between the occurrence of azole -resistant A. fumigatus  in the environment and the spread 
of azole -resistant Aspergillus  in infected patients. In the light of this potential conc ern for 
an increasing prevalence of azole -resistant strains in A. fumigatus  and taking into account 
the precautionary principle, restricting the use of products containing metconazole to 
professional users only is considered appropriate.  
Existing authorisa tions will need to be amended or withdrawn following renewal of 
authorisation in accordance with Article 43 of Regulation (EC) No 1107/2009; 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: 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  
Conclusion on the peer review of the pesticide risk assessment of the active substance 
metconazole E FSA Journal 2023, doi: 10.2903/j.efsa.2023.8141.  
9. Proposed date of adoption:  3rd quarter 2024  
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 text is available on the EU -TBT Website : http://ec.europa.eu/growth/to ols-
databases/tbt/en/  
https://members.wto.org/crnattachments/2024/TBT/EEC/24_01674_00_e.pdf  
https://members.wto.org/crnattachments/2024/TBT/EEC/24 _01674_01_e.pdf