G/TBT/N/EU/928  
28 September 2022  
(22-7273) 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 CC CN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Captan 
(pesticide active substance)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regul ation renewing the approval of the active substance 
captan in accordance with Regulation (EC) No 1107/2009 of the European Parliament and 
of the Council concerning the placing of plant protection products on the market, and 
amending the Annex to Commission  Implementing Regulation (EU) No 540/2011; (4 
page(s), in English), (3 page(s), in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance captan is renewed with restriction to u ses in 
greenhouses, in accordance with Regulation (EC) No 1107/2009. EU Member States shall 
amend/withdraw authorisations for plant protection products containing captan as an 
active substance. The restricted renewal of approval is based on the first evalu ation 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. Separate action will likely be taken on MRLs and 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 demonstrate d that the substance is not harmful to human health, G/TBT/N/EU/928  
 
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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.  
During the evaluation and peer -review of  captan, a number of concerns and areas that 
could not be finalised were identified. These are detailed in the conclusion of the European 
Food Safety Authority (EFSA) and reported here after:  
· Risk to wild non -target terrestrial vertebrates,  
· Risk to wil d non -target terrestrial organisms other than vertebrates,  
· Risk to aquatic organisms.  
These concerns and areas that could not be finalised mean that not all the uses of captan 
meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and onl y uses 
restricted to greenhouses (with the obligation that they remain closed from the time of 
application until harvest) can be currently approved.  
Existing authorisations will need to be amended or withdraw line with Article 43 of 
Regulation 1107/2009; P rotection 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 
captan.  
EFSA (European Food Safety Authority), 2020. Conclusion on the peer revi ew of the 
pesticide risk assessment of the active substance captan. EFSA Journal 2020;18(8):6230.  
9. Proposed date of adoption:  1st 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 text is available on the EU -TBT Website : http://ec.europa.eu/growt h/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2022/TBT/EEC/22_6607_00_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/EEC/22_6607_01_e.pdf