EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12106/2016 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 clothianidin  
(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 clothianidin  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having reg ard to 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/EEC1, and in particular the second  
alternative of Article 21(3) , Article 49(2)  and Article 78(2) thereof,  
Whereas:  
(1) The active substance clothianidin  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 200 6/41/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 clothianidin  and required the applicant  to provide confirmatory information 
as regards:  
(a) the risk to pollinators other than honey bees;  
(b) the risk to honey bees foragin g 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 development, an d the risk to bee brood resulting from such 
exposure;  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2006/41/EC of 7 July 2006 amending Council Directive 91/414/EEC to include 
clothianidin and pethoxamid as active substances  (OJ L 187, 8.7.2006, p. 24 ). 
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 use 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 and long t erm 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 s submitted additi onal information concerning bees  
(ie. h oney bees, bumble bees and solitar y bees) to the rapporteur Member State 
Belgium  within the time period provided for its submission.  They provi ded updated 
dossier s in March  2015 and June  2015.  
(5) Belgium  assessed the additional information submitted by the applicant s. 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 31 August  2015 . 
(6) The Commission consulted the Authority which presented its opinion  on the risk 
assessment of clothianidin  on 13 October  20165. The Authority identified for most 
crops high acute risks for bees from plant protection products containing the active 
substance clothianidin. In particular, as regards exposure via dust, the Aut hority 
identified high acute risks for bees for winter cereal s and high chronic risks to bees 
cannot be excluded for sugar beets. For the consumption of residues in contaminated 
pollen and nectar , high acute and chronic risks were identified or a high risk  cannot be 
excluded for most field uses. Chronic and acute risks to bees were also identified in 
the succeeding crops for all field uses. For forestry nursery, no data was provided by 
the applicant s and risks to bees can therefore not be excluded. Furtherm ore the 
Authority identified a number 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, An imals, Food and Feed and finalised on 
XXX  2017  in the form of a revised  addendum to the Commission review report for 
clothianidin . 
(8) The Commission invited the applicant s to submit their comments on the  revised 
addendum to the  review report for clothianidin . The applicant s submitted their 
comments which have been car efully examined.  
(9)  Having reviewed the information submitted by the applicant, t he Commission has 
concluded that further risks to bees cannot be excluded without imposing  further 
restrict ions. Bear ing 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 clothianidin  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.  
                                                 
5 EFSA (European Food Safety Authority), 2016. C onclusion on the peer review of the pestic ide risk 
assessment for the active substa nce clothianidin in light of con ﬁrmatory data submitted. EFSA Journal 
2016;14(11):4606, 34 pp. doi:10.2903/j. efsa.2016.4606 .  
EN 4   EN (11) Taking into account the risks for bees from treated seeds,   the placing on the market 
and the use of seeds treated with plant protection products containing clothianidin  
should be subject to the same restrictions as the use of clothianidin. It is therefore 
appropriate to provide that seeds treated with plant protection products containing 
clothianidin  shall not be placed on the market or used, except where the  seeds  are 
intended to be used only in  permanent greenhouses  and  the resulting crop s tays within 
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 clothianidin . 
(13) For plant protection products containing clothianidin, where Member States grant a 
grace period pursuant to Article 46 of Regulation (EC) No 1107/2009, that period 
should, at the latest, expire on [ Office of Publications please insert date 6  months from 
the date of entry into force ]. 
(14) The prohibit ion 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 clothianidin 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 S tates shall , in accordance with Regulation (EC) No 1107/2009, where necessary 
amend or withdraw existing authorisations for plant protection products containing 
clothianidin  as active substance by [Office of Publications 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 po ssible 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 in to force ] as regards seeds which have been 
treated with plant protection products containing  clothianidin . 
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 t he Eu ropean 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 JUNCKER