EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10395/2015 Rev. 1  
[…](2016) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance diquat, 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 
Implementin g Regulation (EU) No 540/2011  
(Text with EEA relevance)   EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning  the non -renewal of approval of the active substance diquat, 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 
Implementing Regulati on (EU) No 540/2011  
(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 2009 conc erning the placing of plant protection products on the market 
and repealing Council Directives 79/117/EEC and 91/414/EEC1, and in particular 
Article  20(1) and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2001/21/EC2 included diquat  as an active substance in Annex I 
to Council  Directive 91/414/EEC3. 
(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 (E U) No 540/20114. 
(3) The approval of the active substance diquat , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011, expires on 30  June 2017.  
(4) An application for the renewal of the inclusion of diquat  in Annex I to Directive 
91/414/EEC was submitted in accordance with Article 4 of Commission Regulation 
(EU) No 1141/20105 within the time period provided for in that Article.  
(5) The applicant s submitted the supplementary dossiers  required in accordance with 
Article  9 of Regulation (E U) No 1141/2010.  The application  was found to be complete 
by the rapporteur Member State . 
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2001/21/EC of 5 March 2001  amending Annex I to Council Directive 
91/414/EEC concerning the placing of plant protection products on the market to include amitrole, 
diquat, pyridate and thiabendazole as active substances ( OJ L 69, 10.3.2001, p. 17 –21). 
3 Council  Directive 91/414/EEC  of 15 July 1991 concerning the placing of plant protection products on 
the market  (OJ L 230, 19.8.1991, p. 1).  
4 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation 
(EC) No 1107/2009 of the European Parliament and of t he Council as regards the list of approved active 
substances (OJ L 153, 11.6.2011, p. 1).  
5 Commission Regulation (EU) No 1141/2010 of 7 December 2010  laying down the procedure for the 
renewal of the inclusion of a second group of active substances in Anne x I to Council 
Direc tive 91/414/EEC and establishing the list of those substances  (OJ L 322, 8.12.2010, p. 10) . EN 3   EN (6) The rapporteur Member State prepared a renewal assessment report in consultation 
with the co -rapporteur Member State and submitted it to the European Food Safety 
Authority (hereinafter ‘the Authority’) and the Commission on 28 September  2014.  
(7) The Authority communicated the renewal assessment report to the applicant and to the 
Member States for comments and forward ed the comments received to the 
Commission. The Authority also made the supplementary summary dossier available 
to the public.  
(8) On 12 November  2015 the Authority communicated to the Commission its 
conclusion6 on whether diquat  can be expected to meet the approval criteria provided 
for in Article  4 of Regulation (EC) No 1107/2009. The Authority identified  a high risk 
to workers, bystanders and residents. In addition a high risk to birds w as identified.  
(9) The Commission invited th e applicant s to submit their comments on the conclusion of 
the Authority and, in accordance with Article 1 7(1) of Regulation (E U) No 1141 /2010, 
on the draft review report. The applicant s submitted their comments, which have been 
carefully examined.  
(10) However , despite the arguments put forward by the applicant s, the concerns related to 
the substance  could  not be eliminated.  
(11) Consequently, it has not been established that it may be expected that, with respect to 
one or more representative uses of at least one plant protection product containing 
diquat, the approval criteria provided for in Article 4 of Regulation (EC) 
No 1107/2009 are satisfied. The approval of the active substance diquat should 
therefore not be renewed .  
(12) Member States should be provided with time  to withdraw authorisations for plant 
protection products containing diquat . 
(13) For plant protection products containing diquat , where Member States grant any grace 
period in accordance with A rticle 46 of Regulation (EC) No 1107/2009, that period 
should, at the latest , expire  on 31 March  2018. 
(14) This Regulation does not prejudice the submission of a further application for diquat  in 
accordance with  Article 7 of Regulation (EC) No 1107/2009.  
(15) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of approval of active substance  
The approval of the active substance  diquat  is not renewed .  
Article 2  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing diquat  
as active substance by 31 March  2017 . 
                                                 
6 EFSA (European Food Safety Authority), 2015. Conclusion on the peer review of the pesticide risk 
assessment of the active substance diquat.  EFSA Journal 2015;13(11):4308, 127 pp. 
doi:10.2903/j.efsa.2015.4308   EN 4   EN Article 3 
Grace periods  
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 on  31 March 2018  at the latest.  
Article 4 
Amendments to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (E U) No 540/2011 , row 15 on diquat  is 
deleted.  
Article 5 
Entry into force  
This Regulation shall enter into force on 1 January  2017.  
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