EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10448/2019 rev 1  
[…](2019) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance thiacloprid, 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 th e Annex to Commission Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance thiacloprid, 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 the Annex to Commission Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)  
THE E UROPEAN 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 
Article  20(1)  and Article 78 (2) thereof,  
Whereas:  
(1) Commission Directive 2 004/99/EC2 included thiacloprid  as an active substance in 
Annex I to Council Directive 91/41 4/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 (EU) No  540/20114. 
(3) The approval of the active substance thiacloprid as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011, expires on 30 April  2020 . 
(4) An application for the renewal of the approval of thiacloprid was submitted in 
accordance with Article 1 of Commission Implementing Regulation (EU) 
No 844/20125 within the time period provided for in that Article.  
(5) The applicant submitted the supplementary dossiers requ ired in accordance with 
Article  6 of Implementing  Regulation (EU) No  844/2012. The application was found 
to be complete by the rapporteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2004/99/EC of 1 October 2004 amending Council Directive 91/414/EEC to 
include acetamiprid and thiacloprid as active substances  (OJ L 309, 6.10 .2004, p. 6 ). 
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 the Council as regards the list of approved active 
substanc es (OJ L 153, 11.6.2011, p.  1). 
5 Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the 
provisions necessary for the implementation of the renewal procedure for active substances, as provided 
for in Regulation (EC) No 110 7/2009 of the European Parliament and of the Council concerning the 
placing of plant protection products on the market  (OJ L 252, 19.9.2012, p.  26). EN 2  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 Foo d Safety 
Authority (‘the Authority’) and the Commission on 31 October  2017.  
(7) The Authority communicated the renewal assessment report to the applicant and to the 
Member States for comments and forwarded the comments received to the 
Commission. The Authority  also made the supplementary summary dossier available 
to the public.  
(8) On 22 January  2019  the Authority communicated to the Commission its conclusion6 
on whether thiacloprid can be expected to meet the approval criteria provided for in 
Article  4 of Regulati on (EC) No  1107/2009.  
(9) The Authority identified a  critical concern in relation to the contamination of 
groundwater by metabolites of thiacloprid. In particular, metabolites M30, M34 and 
M46 are predicted to occur above the parametric drinking water limit of 0,1 μg/L in all 
pertinent scenarios for all proposed uses of thiacloprid. These metabolites are considered 
a priori  of concern since it cannot be excluded that they share the same carcinogenic 
properties of the parent active substan ce thiacloprid , which is clasified in accordance with 
Regulation (EC) No  1272/2008 of the European Parliament and of the Council7 as 
carcinogenic  category 2 . Therefore, it cannot currently be established that the presence of 
metabolites of thiacloprid in g roundwater will not result in unacceptable effects on 
groundwater and in harmful effects on human health.  The Authority also concluded that 
the assessment of the risks to aquatic organisms, bees and non -target terrestrial p lants 
could not be finalised base d on the information provided in the dossier.  
(10) Additionally,  thiacloprid is classified  in accordance with Regulation (EC) No  1272/2008  
also as toxic for reproduction category  1B. The applicant provided information 
attempting to  demonstrat e that exposure of humans to thiacloprid can be considered 
negligible. The Authority presented the outcome of the assessment of that informaiton in 
its conclusion. Nevertheless, given the concerns identified  in recital 9 , a conclusion on 
whether e xposure to  humans is negligible for the purposes of point 3.6.4 of Annex II to 
Regulation (EC) No 1107/2009 , is not necessary for the decision on whether the 
approval of thiacloprid can be renewed.  
(11) Furthermore, g iven the  concerns  identified , it is also not possible to provide for an 
approval in accordance with Article 4(7) to Regulation (EC) No  107/2009.  
(12) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority. Furthermore, in accordance with  the third paragraph of  Article 14(1)o f 
Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to 
submit comments on the draft renewal report. The applicant submitted its comments, 
which have been carefully examined.  
(13) However, despite the arguments put forward by the app licant, the concerns regarding 
the active substance could not be eliminated.  
                                                 
6 EFSA Journal (2019) . Conclusion on the peer review of the pesticide risk assessment of the active 
substance thiacloprid . EFSA Journal 2019;17(3):5595. doi: 10.2903/j.efsa.2019.5595      
7 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, a mending and repealing 
Directives  67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907 /2006 (OJ L 353, 
31.12.2008, p.  1). EN 3  EN (14) Consequently, it has not been  established with respect to one or more representative 
uses of at least one plant protection product that the approval criteria provided for in 
Article 4 of Regulation (EC) No  1107/2009 are satisfied. It is therefore appropriate not 
to renew the approval of the active substance thiacloprid in accordance with 
Article  20(1)(b) of that Regulation.  
(15) Implementing Regulation (EU) No 540/2011 should therefore  be amended 
accordingly.  
(16) Member States should be given  sufficient time to withdraw authorisations for plant 
protection products containing thiacloprid . 
(17) For plant protection products containing thiacloprid, where Member States grant any 
grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that 
period should  not exceed 12 months.  
(18) Commission Implementing Regulation (EU) 2019/1688 extended the approval period  
of thiacloprid to 30 April  2020  in order to allow the renewal process to be completed 
before the expiry of the that approval period . However, g iven that a decision on the 
non-renewal of the approval is  taken ahead of th e expiry of that extended approval 
period , this Regulation should apply as soon as possible.  
(19) This Regulation does  not prevent  the submission of a further application for the 
approval of thiacloprid pursuant to  Article 7 of Regulation (EC) No  1107/2009.  
(20) 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 the approval of  the active substance  
The approval of the active substance thiacloprid is not renewed.  
Article 2  
Amendment  to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011 row 92, on thiacloprid, 
is deleted.  
                                                 
8 Commission Implementing Regulation (EU) 2019/168 of 31 January 2019 amending Implementing 
Regulation (EU) No 540/2011 as r egards the extension of the approval periods of the active substances 
abamectin, Bacillus subtilis (Cohn 1872) Strain QST 713, Bacillus thuringiensis subsp. Aizawai, 
Bacillus thuringiensis subsp. israeliensis, Bacillus thuringiensis subsp. kurstaki, Beauve ria bassiana, 
benfluralin, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop -P, 
epoxiconazole, fenpyroximate, fluazinam, flutolanil, fosetyl, Lecanicillium muscarium, mepanipyrim, 
mepiquat, Metarhizium anisopliae var. Ani sopliae, metconazole, metrafenone, Phlebiopsis gigantea, 
pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, Pythium oligandrum, rimsulfuron, 
spinosad, Streptomyces K61, thiacloprid, tolclofos -methyl, Trichoderma asperellum, Trichoderma 
atroviride, Trichoderma gamsii, Trichoderma harzianum, triclopyr, trinexapac, triticonazole, 
Verticillium albo -atrum and ziram ( OJ L 33, 5.2.2019, p.  1). EN 4  EN Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
thiacloprid as active substance by [ Publications Office please insert date 6 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 expire by [Publications  Office  please insert date 1 2 months from the date 
of entry into force ] at the latest.  
Article 5  
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 .  
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  