EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/00102/2015 Rev 1  
[…](2018) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance pymetrozine, 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 Commis sion Implementing 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 pymetrozine, 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 Commission Imple menting Regulation (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 O ctober 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 2001  /87/EC2 included pymetrozine  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 Commi ssion Implementing Regulation (EU) No 540/20114. 
(3) The approval of the active substance pymetrozine , as set out in Part  A of the Annex to 
Implementing Regulation (EU) No  540/2011 , expires on 30 June 2018. 
(4) An application for the renewal of the approval  of pymetrozine  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 required 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 2001/87/EC of 12 October 2001 amendi ng Annex I to Council 
Directive  91/414/EEC concerning the placing of plant protection products on the market to include 
acibenzolar -s-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufen -ethyl as active 
substances  (OJ L 276, 19.10.2001, p. 17).  
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 amending implementing 
Regulation (EC) No 1107/2009 of the Europea n Parliament and of the Council as regards the list of 
approved active substances (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 ren ewal procedure for active substances, as provided 
for in Regulation (EC) No 1107/2009 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 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 (‘the Authority’) and the Commission on 28 June 2013 . 
(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 28  August  2014  the Authority communicated to the Commission its conclusion6 on 
whether pymetrozine  can be expected to meet the approval criteria provided for in 
Article  4 of Regulation (EC) No  1107/2009. The Authority concluded that there is a 
high potential for the representative uses assessed to result in groundwater exposure 
above the parametric drinking water limit of 0.1  μg/l by the toxicologically relevant 
metabolite CG A371075 in all pertinent groundwater scenarios . The Authority  further 
concluded that  several other toxicologically relevant metabolites of pymetrozine are 
also predicted to occur above 0.1  μg/L in some or all pertinent groundwater scenarios 
for the representative uses evaluated. It also concluded that the toxicological profile of 
metabolites included in the plant residue definition for risk assessment could not be 
confirmed based and that the assessment of the risk to aquatic organi sms from exposure 
to metabolite M3MF could not be ﬁnalised for all representative uses considered based 
on the information available  in the dossier .  
(9) In addition, pymetrozine is classified as carcinogen category 2  in accordance with 
Regulation (EC) No  1272/2008 of the European Parliament and of the Council7, while 
in the conclusion of the Authority it is indicated that pymetrozine is also to  be 
classified as  toxic for reproduction category  2. Moreover , on 30 May 2017 the 
rapporteur Member State submitted a dossier with a proposal for harmonised 
classification of pymetrozine in accordance with Article  37 of Regulation (EC) 
No 1272/2008 . It proposed to have a classification  in category  2 for the hazard class 
on reproductive toxicity  and  to maintain  the classification in  category 2 for the hazard 
class on carcinogenicity. Therefore pymetrozine shall  be considered to have endocrine 
disrupting properties in accordance with the interim criteria set out in the third 
subparagraph of point 3.6.5 of Annex  II to Regulation (EC) No  1107/2009.  Moreover, 
pymetrozine caused  adverse effects on endocrine organs across different species and 
timelines , however, the scientific assessment for potential endocrine disruption 
properties of pymetrozine could not be finalised  based on the information available in 
the dossier . Given the concerns mentioned in recital  8, a conclusion on whether the 
requirements set out in P oint 3.6.5 of Annex  II to Regulation (EC) No  1107/2009 with 
respect to negligible exposure are satisfied or not  was not considered necessary.  
(10) Given the concerns mentioned in recital 8 , the derogation provided for in Article  4(7) 
of Regulation (E C) No  1107/2009 cannot apply . The application of that derogation is 
also excluded as it has not been established that any of the criteria set out in 
point s 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex  II to Regulation (EC) No  1107/2009 are not 
satisfied .  
                                                 
6 EFSA (European Food Safety  Authority), 201 4. Conclusion on the peer review of the pesticide ri sk 
assessment of the active substance pymetrozine . EFSA Jour nal 2014;12(9 ):3817 , 102 pp. 
doi:10.2903/j.efsa.201 4.3817 .  
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, am ending 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 4   EN (11) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority  and, in accordance with Article  14(1) of Implementing Regulation (EC) 
No 844/2012, on the draft renewal report . The applicant submitted its comments, 
which have been carefully examined.  
(12) However, des pite the arguments put forward by the applicant, the concerns related to 
the substance could not be eliminated.  
(13) 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 pymetrozine  in accordance with 
Article  20(1)(b) of that Regulation.  
(14) Implementing Regula tion (EU) No 540/2011 should therefore be amended 
accordingly . 
(15) Member States should be allowed sufficient time to withdraw authorisations for plant 
protection products containing pymetrozine .  
(16) For plant protection products containing pymetrozine , where Mem ber States grant any 
grace period  in accordance  with Article  46 of Regulation (EC) No  1107/2009, that 
period should, at the latest, expire on [Office of Publications please insert date 15 
months from the date of entry into force] .  
(17) This Regulation does not prevent  the submission of a further application for the 
approval of pymetrozine  pursuant to Article  7 of Regulation (EC) No  1107/2009.  
(18) 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 pymetrozine  is not renewed.   
Article 2  
Amendments to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Re gulation (EU) No 540/2011, row 23 , on 
pymetrozine , is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
pymetrozine  as active substance by [Office of Publications please insert date 6 months  from  
the date of entry into force ] at the latest.  EN 5   EN 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 15 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