G/SPS/N/EU/608  
 
16 January 2023  
(23-0368) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Ipconazole (pesticide active substance)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Commission Implementing Regulation withdrawing 
the approval of the active substance ipconazole in accordance with Regulation (EC) 
No 1107/2 009 of the European Parliament and of the Council, amending Commission 
Implementing Regulation (EU) No 540/2011 and repealing Commission Implementing 
Regulation (EU) No 571/2014 (Text with EEA relevance) . Language(s):  English . Number 
of pages:  5 
https://members.wto.org/crnattachments/2023/SPS/EEC/23_0435_00_e.pdf  
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the approval of the active substance ipconazole is withdrawn in accordance with Regulation 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 1107/2009.  
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.  
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 as 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 Re gulation (EU) 2020/1182 amended Annex 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.  
Furthe rmore, a high long -term risk to birds 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 app roval should therefore be withdrawn.  G/SPS/N/EU/608  
 
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  Existing authori zations will need to be withdrawn; EU member States must withdraw 
existing plant protection products containing ipconazole at the latest by three 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 six months from the 
entry into force.  
This decision only concerns the placing on the market of this substance and plant 
protection products containing it. F ollowing 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.  
This draft Comm ission Implementing Regulation was also notified under the 
TBT Agreement in notice G/TBT/N/EU/944.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [X]  plant protection, 
[X] protect humans from animal/plant pest or disease, [X]  protect terr itory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international st andard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:   
− 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 review 
of the approval of the active substance ipc onazole. 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 June 2011, 
p. 1–186) 
http://eur -lex.europa.eu/l egal-
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, Regulation (EC) 
No 1272/2008 of the European Parlia ment and of the Council on classification, labelling 
and packaging of substances and mixtures ( OJ L 261, 11 August 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 repeal ing 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  G/SPS/N/EU/608  
 
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  10. Proposed date of adoption (dd/mm/yy) : 2nd quarter 2023  
Proposed date of publication (dd/mm/yy) : 2nd quarter 2023  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 20 days following its publication in the Of ficial Journal of the 
European  Union.  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable. Comments are only welcomed on 
TBT related issues and to b e addressed to the TBT Enquiry Point on notice 
G/TBT/N/EU/944.  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (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  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax numb er and e -mail address (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