G/TBT/N/EU/566  
 
11 April 2018  
(18-2166) 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 
Commission,  
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 [   ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable): Dithianon 
(pesticide active substance)  
Pesticides and other agrochemicals (ICS 65.100)  
5. Title, number of pages and language(s) of the notified document: Draft 
Commission Implementing Regulation amending Implementing Regulation 
(EU) No 540/2011 as regards the conditions of approval of the active substance dithianon 
(and its accompanying annex)  (4 + 2 pages, in English)   
6. Description of content: This draft Commission Implementing Regulation provides that 
the conditions of approval of the active substance dithianon are amended. Existing 
authorisations for plant protection products containing dithianon will be amended or 
withdrawn from the market. T he amendment is based on evaluation of confirmatory 
information submitted following the approval of the substance for use as a pesticide active 
substance in the EU under Regulation (EC) No 1107/2009.  
This decision only concerns the placing on the market o f this substance and does not affect 
the Maximum Residue Levels (MRLs) for residues of the concerned pesticide.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health or safety; Protection of anima l or plant life or 
health; Protection of the environment.  
During the evaluation and peer -review of the confirmatory data provided on dithianon 
following its approval (Commission Implementing Directive 2011/41/EU), it was identified 
that the consumer exposu re assessment could not be concluded given the data gaps 
identified for storage stability data on dithianon residues in grape wine, and for the 
magnitude of the metabolites Reg. No. 4107273, Reg. No. 31062, Reg. No. 4005234 
(Phthalic acid) and Reg. No. 411 0933 in   apple   and  grapes   processed   commodities. This 
is indicated as a critical area of concern in the conclusion of the European Food Safety G/TBT/N/EU/566  
 
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  Authority (EFSA) published in August 2015.  
In order to ensure the protection of consumers it is necessary to amend the approval to 
include a restriction of use. Dithianon will be restricted to use on non -edible crops only.  
Existing authorisations will need to be amended or withdrawn; EU Member States must 
amend or withdraw existing plant protection products conta ining dithianon 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 15 months from the date 
of withdrawal of the authorisation.  
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/?qid=1521642425074&uri=CELEX:32009R1107  
Commission Implementing Regulation (EU) No  540/2011 of 25  May 2011 imp lementing 
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 Implementing Directive 2011/41/EU of 11 April 2011 amending Council 
Directive 91/414/EEC to include dithianon as active substance and amending Com mission 
Decision 2008/934/EC ( OJ L 97, 12 .4.2011, p. 38 –41) 
http://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX:32011L0041  
EFSA (European Food Safety Authority), 2015. Conclusion on the peer review of the 
pesticide risk assessment for the active substance dithianon in light of confirmatory data. 
EFSA Journal 2015;13(11):4278 20 pp. doi: 10.2903/j.efsa.2015.4278  
https://www.efsa.europa.eu/en/efsajournal/pub/4278   
9. Proposed date of adoption: 4th quarter 2018  
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/tools -databases/tbt/en/  
https://members.wto.org/crnattachments/2018/TBT/EEC/18_1951_00_e.pdf  
https://members.wto.org/crnattachments/2018/TBT/EEC/18_1951_01_e.pdf