EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10574/2021  
[…](2021) 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 penflufen and repealing Implementing Regulation (EU) 
2018/185  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of 
approval  of the active substance penflufen and repealing Implementing Regulation (EU) 
2018/185  
(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 Article 
21(3) , second alternative  in conjunction  with Article 6 thereof , and Article 78(2) thereof , 
Whereas:  
(1) Commission Implementing Regulation (EU) No 1031 /20132 approv ed the active 
substance penflufen  and added it to Part B of  the Annex to Commission Implementing 
Regulation (EU) No  540/20113, subject to certain conditions, requiring, in particular, 
the submission of confirmatory information in accordance with Article  6 of Regulation 
(EC) No  1107/2009.  
(2) Commission Implementing Regulation (EU) 2018/1854 amended the conditions of 
approval of the a ctive substance penflufen  and addressed part of the confirmatory 
information required by Implementing Regulation (EU ) No 1031 /2013. 
(3) Implementing Regulation (EU ) No 1031 /2013 also provides for the submission of 
further confirmatory information as regards the relevance of the metabolite  M01 
(penflufen -3-hydroxy -butyl) for groundwater if penflufen is classified , under 
Regulation (EC) No  1272/2008  of the European Parliament and of the Council5, as 
‘carcinogen category 2 ’ within 6  months from the notification of the classification 
decision concerning that substance.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Implementing Regulation (EU) No  1031/2013 of 24  October 2013 approving the active 
substance penflufen, 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 ( OJ L 283, 25.10.2013, p.  17). 
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) 2018/185 of 7 February 2018 amending Implementing 
Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance penflufen 
(OJ L 34, 8.2.2018, p.  13). 
5 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, amending 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 2  EN (4) On 15 October 2018 , the European Chemical Agency’s Committee for Risk 
Assessment  adopted an opinion6 in which it concluded  that penflufen should be 
classified as ‘carcinogen category 2 ’. Following that opinion, and since Member States 
agreed with such a classification, penflufen was included in the list of harmonised 
classification and labelling of hazardous substances  provided for in Annex VI to 
Regulation (EC) No 1272/2008.  
(5) On 15 March 2 019, the applicant informed Poland, the rapporteur Member State , that 
it would not submit the required confirmatory information, which was only relevant 
for the representative use to treat seed potato tubers before or during planting . 
(6) Since the information  required in accordance with Art icle 6(f) of Regulation (EC) 
No 1107/2009 has not been provided, the Commission informed the Member States, 
the Authority and the producer of the active substance  penflufen  that a Regulation will 
be proposed to withdraw  the approval  or to amend the  conditions of  approval  of 
penflufen .  
(7) On 19 February 2021 t he applicant was given the possibility to submit comments and 
any relevant information  to the Commission . The applicant submitted its  comments 
confirming that it would not submit the confirmatory information  requested.  
(8) The Commission has concluded that  the available data  is not sufficient to  determine 
the relevance of the m etabolite M01  (penflufen -3-hydroxy -butyl) , which is predicted 
to occur above 0.1 µg/L in all relevant g roundwater scenarios when seed potato tubers 
treated with penflufen are planted, as the information required in Implementing 
Regulation (EU) No 1031/2013 has not been provided . 
(9) Therefore, it is necessary and appropriate to restrict the approval of penflufe n and 
prohibit the treatment of seed potato tubers  before  or during plant ing, while it is 
possible to maintain the use of penflufen to treat  cereal  seeds , since safe  uses have  
been demonstrated . 
(10) The Annex to Implementing Regulation (EU) No 540/2011  should therefore be 
amended accordingly.  
(11) For the sake of clarity, and since the amendments made by this Regulation make 
Implementing Regulation (EU) 2018/185  redundant, it is also appropriate to repeal 
Regulation (EU) 2018/185 . 
(12) Member States should be provided wi th sufficient time to amend or withdraw 
authorisations for plant protection products containing penflufen  which are not 
complying with the restricted conditions of approval.  
(13) For plant protection products containing penflufen , where Member States grant any 
grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this 
period should expire at the latest 18 months after the entry into force of this 
Regulation.  
(14) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
                                                 
6  Opinion of 15 October 2018 concerning 5 -fluoro -1,3-dimethyl -N-[2-(4-methylpentan -2-yl)phenyl] -
1Hpyrazole -4-carboxamide;2’ -[(RS) -1,3-dimethylbutyl] -5-fluoro -1,3-dimethylpyrazole -4-
carboxanilide; penflufen (CLH -O-0000001412 -86-233/F )  
EN 3  EN HAS ADOPTED THIS REGULATION:  
Article 1 
Amendment  to Implementing Regulation (E U) No 540/2011  
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the 
Annex to this Regulation.  
Article 2 
Repeal of Implementing Regulation (EU) 2018/185  
Implementing Regulation (EU) 2018/185  is repealed.  
Article 3  
Transitional measures  
Member States shall, where necessary , amend or withdraw existing authorisations for plant 
protection products containing penflufen as active substance  by [Publication s office please 
insert date 3 months after date of entry into force ]. 
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 on  [Publications office please 
insert da te 6 months after date of entry into force ] at the latest . 
 
Article 5 
Entry into force  
This Regulation shall enter into force on the twentie th 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  
 Ursula VON DER LEYEN