G/TBT/N/EU/944  
10 January 2023  
(23-0265) 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):  Ipconazole 
(pesticide active substance)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing R egulation withdrawing the approval of the active substance 
ipconazole in accordance with Regulation (EC) No 1107/2009 of the European Parliament 
and of the Council, amending Commission Implementing Regulation (EU) No 540/2011 
and repealing Commission Imple menting Regulation (EU) No 571/2014; (5 page(s), in 
English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance ipconazole is withdrawn in accordance with 
Regulation (EC) No 1107/200 9. 
EU Member States shall withdraw authorisations for plant protection products containing 
ipconazole as an active substance.  
This decision only concerns the placing on the market of this substance and plant 
protection products containing it. Following withdrawal of approval and the expiry of all 
grace periods for stocks of products containing this substance, separate action may be 
taken on MRLs in which case a separate notification will be made in accordance with SPS 
procedures.  
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 demonst rated that the substance is not harmful to human health, G/TBT/N/EU/944  
 
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  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.  
Active substances may be reviewed at  any time where in the light of new scientific and 
technical knowledge there are indications that the substance no longer satisfies the 
approval criteria laid down in Article 4 of Regulation (EC) No 1107/2009.  
Substances that are or have to be classified a s toxic for reproduction category 1B (R1B) 
according to Regulation (EC) No 1272/2008 cannot be approved unless exposure to 
humans is demonstrated to be negligible under realistic conditions of use.  
Commission Delegated Regulation (EU) 2020/1182 amended Ann ex VI to Regulation (EC) 
No 1272/2008 and classified ipconazole as toxic for reproduction category 1B.  
Negligible exposure to ipconazole for humans could not be concluded due to limitations 
with the available data.  
Furthermore, a high long -term risk to bir ds from the representative uses of ipconazole 
was concluded by the European Food Safety Authority.  
This means that ipconazole no longer fulfils the approval criteria as outlined in Regulation 
(EC) No 1107/2009 and the approval should therefore be withdrawn.  
Existing authorisations will need to be withdrawn; EU Member States must withdraw 
existing plant protection products containing ipconazole at the latest by 3 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 6 months from the entry into force; 
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  
EFSA Panel (European Food Safety Authority), 2022. Statement concerning the revi ew of 
the approval of the active substance ipconazole. EFSA Journal 2022;20(8):7133, 26 pp. 
https://doi.org/10.2903/j.efsa.2022.7133  
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 Delegated Regulation (EU) 2020/1182 of 19 May 2020 amending, for the 
purposes of its adaptation to technical and scientific progress, Regulati on (EC) No 
1272/2008 of the European Parliament and of the Council on classification, labelling and 
packaging of substances and mixtures ( OJ L 261, 11.8.2020, p. 2).  
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A32020R1182  
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 
December 2008 on classification, labelling and packaging of substances and mixtures, 
amending and repealing  Directives 67/548/EEC and 1999/45/EC, and amending 
Regulation (EC) No 1907/2006  
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=celex%3A32008R1272  
9. Proposed date of adoption:  2nd quarter 2023  
Proposed date of entry into force:  20 days following publication in the Official Journal 
of the EU  G/TBT/N/EU/944  
 
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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 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_0304_00_e.pdf