EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12105/2016 rev 5  
[…](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 imidacloprid  
(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 imidacloprid  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to R egulation (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/EEC1, and in particular the second 
alterna tive of Article 21(3) , Article 49(2) and Article 78(2) thereof,  
Whereas:  
(1) The active substance imidacloprid  was 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  2008/116/EC2. 
(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) Regulation (EU) No 485/20134 amended the conditions of approval of the active 
substance imidacloprid  and required the applicant to provide confirmatory information 
as regards:   
(a) the risk to pollinators other than honey bees;  
(b) the risk to honey bee s foraging in nectar or pollen in succeeding crops;  
(c) the potential uptake via roots to flowering weeds;   
(d) the risk to honey bees foraging on insect honey dew;  
(e) the potential guttation exposure and the acute and the long -term risk to colony 
survival and develo pment, and the risk to bee brood resulting from such 
exposure;  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2008/116/EC of 15 December 2008 amending Council Directive 91/414/EEC to 
include aclonifen, imidacloprid and metazachlor as active substances  (OJ L 337, 16.12.2008, p. 86 ) 
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, 11.6.2011, p. 1).  
4 Commission Implementing Regulation (EU) No 485/2013 of 24 May 2013 amending Implementing 
Regulation (EU) No 540/2011, as regards the conditions of approval of the active substances 
clothianidin, thiamethoxam and imidacloprid, and prohibiting the u se and sale of seeds treated with 
plant protection products containing those active substances (OJ L 139, 25.5.2013, p. 12).   
EN 3   EN (f) the potential exposure to dust drift following drill and the acute and the long -
term risk to colony survival and development, and the risk to bee brood 
resulting from such exposure;  
(g) the acute a nd long term risk to colony survival and development and the risk to 
bee brood for honeybees from ingestion of contaminated nectar and pollen.  
(4) In December 2014 , the applicant submitted additi onal information concerning bees  
(i.e. honey bees, bumble bees an d solitary bees) to the rapporteur Member State 
Germany within the time period provided for its submission.  
(5) Germany 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 and the European Food Safety Authority  (‘the 
Authority’ ) on 18 January  2016 . 
(6) The Commission consulted the Authority which presented its opinion  on the risk 
assessment of imidacloprid  on 13 Octob er 20165. The Authority identified for most 
crops high acute risks for bees from plant protection products containing the active 
substance imidacloprid . In particular, as regards exposure via dust, the Authority 
identified high risks for bees for several field uses. For bees foraging in the treated 
crop, a high risk was identified  for the use on potatoes and winter cereals .  For almost 
all field uses , a high risk to bees was also identified in the succeeding crops. In 
addition,  the Authority identified a nu mber of data gaps.  
(7) The draft assessment report , the addendum  to the draft assessment report  and the 
opinion of the Authority were reviewed by the Member States and the Commission 
within the Standing Committee on Plants, Animals, Food and Feed and finalised on 
XXX  in the form of a revised addendum to the Commission review report for 
imidacloprid .  
(8) The Commission invited the applicant to submit its comments on the  revised 
addendum to the  review report for imidacloprid . The applicant submitted its comments 
which have been car efully examined.  
(9)  Having reviewed the information submitted by the applicant, the  Commission  has 
concluded that further risks to bees cannot be excluded without imposing  further 
restrict ions. Bearing in mind the need to ensure a level of safety and protection 
consistent with the high level of protection of animal health that is sought within the 
Union,  it is appropriate to prohibit all outdoor uses.  Therefore,  it is appropriate to 
limit the use of imidacloprid  to permanent greenhouses and to require that  the 
resulting crop stays its entire life cycle within a permanent greenhouse , so that it is  not 
replanted outside .  
(10) The Annex to Implementing Regulation (EU) No 540/2011 should therefore be 
amended accordingly.  
(11) Taking into account the risk s for bees from treated seeds,  the placing on the market 
and the use of seeds treated with plant protect ion products containing imidacloprid  
should be subject to the same restrictions as the use of imidacloprid . It is therefore 
appropriate to provide that seeds treated with plant protection products containing 
imidacloprid  shall not be placed on the market o r used,  except where the seeds are 
                                                 
5 EFSA (European Food Safety Authority), 2016. Peer review of the pesticide risk assessment for the 
active substance imidacloprid i n light of confirmatory data submitted. EFSA Journal 2016;14(11):4607. 
doi: 10.2903/j.efsa.2016.4607 .  
EN 4   EN intended to be used only in  permanent greenhouses and the resulting crop stays in a 
permanent greenhouse during its entire life cycle .  
(12) Member States should be allowed sufficient  time to amend or withdraw authorisations 
for plant protection products containing imidacloprid .  
(13) For plant protection products containing imidacloprid, where Member States grant a 
grace period pursuant to  Article  46 of Regulation (EC) No  1107/2009, that p eriod 
should, at the latest, expire on [ Office of Publications please insert date 6  months from 
the date of entry into force ]. 
(14)  The prohibition of placing on the market and use of treated seeds should apply only as 
of [Office of Publications please insert date 6 months from the date of entry into force ] 
in order to allow for a sufficient period of transition.  
(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  
Amendment to Implementing Regulation ( EU) No 540/2011  
Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in 
accordance with the Annex to this Regulation.  
Article 2  
Prohibition of the placing on the  market and use of treated seeds  
Seeds treated with plant protection products containing imidacloprid  shall  not be placed on 
the market or used, except where : 
(a) the seeds are intended to be used only in permanent greenhouses , and 
(b) the resulting crop stays within a permanent greenhouse during its entire life cycle .  
Article 3 
Transitional measures  
Member States shall in accordance with Regulation (EC) No 1107 /2009, where necessary 
amend or withdraw existing authorisations for plant prot ection products containing 
imidacloprid  as active substance by [ Office of P ublications please insert date 3  months from 
the date of entry into force ] at the latest.  
Article 4 
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 6 months from the date of entry into force ] at the latest.  
  
EN 5   EN Article 5  
Amendment to  Regulation (EU) No 485/2013  
Article 2 of Regulation (EU) No 485/2013 is deleted  as of [Office of Publications please 
insert date 6  months from the date of entry into force ] as regards seeds which have been 
treated with plant protection products containing  imidacloprid.  
Article  6 
Entry into force  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union.  
However, Article 2 shall apply as of [ Office of Publications please insert date  6 months from 
the date  of entry into force ]. 
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 J UNCKER