EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10834/2016 Rev. 8  
[…](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 thiamethoxam  
(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 thiamethoxam  
(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 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 
altern ative of Article  21(3), Article 49(2)  and Article 78(2) thereof,  
Whereas:  
(1) The active substance thiamethoxam 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 2007/6/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) Regul ation (EU) No 485/20134 amended the conditions of approval of the active 
substance thiamethoxam 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 2007/6/EC of 14 February 2007 amending Council Directive 91/414/EEC to 
include metrafenone, Bacillus subtilis, spinosad and thiamethoxam as active  substances ( OJ L 43, 
15.2.2007 , p. 1 3). 
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 p rohibiting 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) The applicant  submitted additional information concerning bees ( i.e. honey bees, 
bumble bees and solitary bees)  to the rap porteur Member State Spain . 
(5) Spain 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 12  November  2015.  
(6) The Member States, the applicant and the Authority were consulted and asked to 
provide comments on the assessment of the rapporteur Member State. The Authority 
published a Technical Report summarisin g the outcome of this consultation for 
thiamethoxam  on 20 April  20165. 
(7) The draft assessment report, the addendum and the Technical Report of the Authority 
were reviewed by the Member States and the Commission within the Standing 
Committee on Plants, Animal s, Food and Feed and finalised on XXX 2017 in the  form 
of a revised  addendum to the Commission review report for thiamethoxam.   
(8) The Commission invited the applicant to submit its comments on the revised 
addendum to the review report for thiamethoxam. The a pplicant submitted its 
comments which have been carefully examined.   
(9) Having reviewed the info rmation  submitted by the applicant, the Commission has 
conclude d that the further confirmatory information  required by Regulation (EU) 
No 485/2013 has not been provided  and that a n unacceptable risk  to bees and other 
pollinators cannot be excluded without imposing further restrictions . 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 thiamethoxam  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 risks for bees from treated seeds, t he placing on the market 
and the use of seeds treated with plant protection products containing thiamethoxam 
should be subject to the same restrictions as the use of thiamethoxam. It is therefore 
appropriate to provide that seeds treated with plant protection products containing 
thiametho xam 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 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 thiamethoxam.  
(13) For plant protection products containing thiamethoxam, where Member States grant a 
grace period pursuant to  Article 46 of Regulation (EC) No  1107/2009, that per iod 
                                                 
5 EFSA Supporting publication 2016:EN -1020   
EN 4   EN should, at the latest, expire on [Office of Publications please insert date 6  months fro m 
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 se eds 
Seeds treated with plant protection products containing thiamethoxam 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 
thiamethoxam 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 possible and shall expire  by [Office of Publications please 
insert date 6  months from the date of entry into force ] at the latest.  
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 thiamethoxam . 
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 .  
EN 5   EN 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