EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11625/2017  
[…](2017) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of 
approval of the active substance dithianon  
(Text with EEA relevance)   EN 2  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of 
approval of the active substance dithianon  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council of 21 October 20 09 concerning the placing of plant protection products on the market 
and repealing Council Directives 79/117/EEC and 91/414/EEC1, and in particular the second 
alternative of Article  21(3)  and Article 78(2) thereof , 
Whereas:  
(1) The active substance dithianon w as included in Annex I to Council 
Directive  91/414/EEC of 15 July 1991 concerning the placing of plant protection 
products on the market by  Commission Directive 2011/41 /EU2, under the condition 
that the Member States concerned ensure that the applicant , at whose request dithianon  
was included in that Annex , provides further conf irmatory information as regards the 
storage stability and the nature of residues in processed products, the aquatic and 
groundwater exposur e assessment for phthalic acid and the risk  assessment for aquatic 
organisms with respect to phthalic acid, phthalaldehyde and 1,2 benzenedimethanol.   
(2) Active substances included in Annex I to Directive 91/414/EEC are deemed to have 
been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the 
Annex to Commission Implementing Regulation (EU) No 540/20113. 
(3) In May 2013 , the applicant submitted additional information concerning the requested 
confirmatory data  to the rapporteur Member State Greece  within the time period 
provided for its submission.  
(4) Greece  assessed the additional information submitted by the applicant. It submitted its 
assessment, in the form of an addendum  to the draft assessment report, to the other 
Member States, the Commission a nd the European Food Safety Authority  (‘the 
Authority’ ), on 5 December 2013 . 
(5) The submitted information  was considered as adequate by the  rapporteur Member 
State to address all the issues  in the  confirmatory information request . However, some 
Member States disagreed and considered the information was sufficient regarding the 
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Implementing Directive 2011/41/EU of 11 April 2011 amending Council 
Directive  91/414/EEC to include dithianon as active substance and amending Commiss ion 
Decision  2008/934/EC (OJ L 97, 12.4.2011, p. 38 ). 
3 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, 1 1.6.2011, p. 1). EN 3  EN aquatic and groundwater exposure assessment for phthalic acid and the risk 
assessment for aquatic organisms with respect to phthalic acid, phthalaldehyde and 1,2 
benzenedimethanol , but n ot for the storage stability and the nature of residues in 
processed products . 
(6) The Commission therefore consulted the Authority on the outstanding issue of the 
storage stability and the nature of residues in processed products. T he Authority  
presented its conclusion  on the risk assessment of dithianon  on 27 October  20154. The 
draft assessment report, the addendum and the conclusion  of the Authority were 
reviewed by the Member States and the Commission within the Standing Committee 
on Plants, Animals, Food a nd Feed and finalised on  22 March  2018  in the format of 
the Commission review report for dithianon .  
(7) The Commission invited the applicant to submit its comments on the review report for 
dithianon . The applicant submitted its comments which have been carefu lly examined.  
(8) The Commission has come to the conclusion  that the additional  information provided  
showed  that an exposure of consumers to potentially toxicologically relevant 
metabolites through the consumption of pome fruit and grape s processed commodities 
cannot be excluded.  Furthermore, data on the storage stability of  dithianon residues in 
grape wine is lacking.  
(9) The Co mmission has concluded that the  confirmatory information required has not 
been fully provided and that the review of the submitted  additional information failed 
to establish that exposure to certain  potentially toxicologically relevant metabolites 
from the representative uses  of the dithianon on wine grapes and pome fruit,  consistent 
with good plant protection practice, have no harmful effects. An exposure of 
consumers to potentially toxicologically relevant metabolites of dithianon via 
consumption of pome fruit and grapes processed commodities cannot be excluded 
except by imposing further restrictions . In particular, the  use of dithianon  should be 
limited to non -edible crops only.  
(10) It is confirmed  that the active substance dithianon  is deemed to have been approved 
under Regulation (EC) No 1107/2009 . In order to minimise the exposure of consumers 
to the potentially toxicologically relevant metabolites  of dithianon , it is however  
appropriate to amend the conditions of  use of this active substance.  
(11) The Annex to Implementing Regulation (EU) No 540/2011 should therefore be 
amended accordingly.  
(12) Member States should be pro vided with time to amend or withdraw authorisations for 
plant protection products containing dithianon . 
(13) For plant protection products containing dithianon , where Member States grant any grace 
period in accordance with Article 46 of Regulation (EC) No 1107/ 2009, that period 
should , at the latest , expire  on [Office of Publications please insert date 15 months  from 
the date of entry into force] . 
(14) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants,  Animals, Food and Feed , 
                                                 
4 Conclusion on the peer review of the pesticide risk assessment for the active substance dithianon in 
light of confirmatory data submitted. EFSA Journal 2015;13(11):4278. doi: 10.2903/j.efsa.2015.4278 .  EN 4  EN HAS ADOPTED THIS REGULATION:  
Article 1 
Amendment to Implementing  Regulation (EC) No 540/2011  
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the 
Annex to this Regulation.  
Article 2  
Transitional measures  
Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary 
amend or withdraw existing authorisations for plant protection products containing dithianon  
as active substance by [Office of Publications please insert date 6  months  from the date of 
entry into force ] at the latest.  
Article 3 
Grace period  
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) 
No 1107/2009 shall be as short as possible and shall expire  by [Office of Publications please 
insert date 15 months  from the date of entry into force]  at the latest.   
Article 4 
Entry into force  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the E uropean Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President   
 Jean -Claude JUNCKER