EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11003/2016 rev. 1  
[…](2016) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance fenamidone, 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 Commiss ion 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 fenamidone, 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 Implem enting 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 Oc tober 2009 concerning the placing of plant protection products on the market 
and repealing Council Directives  79/11 7/EEC and 91/414/EEC1, and in particular 
Article  20(1)  and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2003/68/EC2 included fenamidone 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 Commission Implementing Regulation (EU) No  540/20114. 
(3) The approval of the active substance fenamidone , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011 , expires on 31 July 2018 . 
(4) An application for the renewal of the approval of fenamidone was submitted in 
accordance with Article 1 of Commission Implementing Regulat ion (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 2003/68/EC of 11 July 2003 amending Council Directive 91/414/EEC to include 
trifloxystrobin, carfentrazone -ethyl, mesotrione, fenamidone and isoxaf lutole as active substances (OJ L 
177, 16.7.2003, p. 12).   
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 
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 renewal 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 o n 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 su bmitted it to the European Foo d Safety 
Authority (  ‘the Aut hority’) and the Commission on 12 February  2015.  
(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 11 February 2016  the Authority communicated  to the Commission its conclusion6 
on whether fenamidone  can be expected to meet the approval criteria provided for in 
Article  4 of Regulation (EC) No 1107/2009.  
(9) The Autority identified specific concerns . In particular , it was not possible to conclude 
on the genotoxic  potential of fenamidone and  no health -based referenc e val ues could be 
set. Consequently, the consumer and non -dietary risk asessements could not be 
conducted. Furthermore,  a high potential for groundwater contamination above the  
parametric drinking water limit of 0.1  μg/L by a toxicologically  relevant metabolit e 
(RPA 412708) was indicated in all pertinent scenarios for crops grown in soils of 
predominantly pH  7 or above. In addition, the Authority concluded that the consumer 
risk assessment  for exposure to another groundwater metabolite  (RPA  412636)  which 
is also found in food of plant and animal origin  could not be finalised . Furtermore , the 
residue definitions for risk assessment in plant and livestock commodities are not 
finalised in terms of the inclusion of potentially relevant metabolite s. Finally, the 
Authority concluded that the risk assessment for wild mammals could not be finalised  
and a high risk to aquatic organisms from exposure to the metabolite acetophone could 
not be excluded  based on the available  information .  
(10) The Commission i nvited the applicant to submit its comments on the conclusion of the 
Authority. Furthermore, in accordance with the third subparagraph of Article  14(1) of 
Implementing Regulation (EC) 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.  
(11) However, despite the arguments put forward by the applicant, the concerns regarding 
the active substance  could not be eliminated.  
(12) 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 appro val of the active substance fenamidone  in accordance with 
Article  20(1)(b) of that Regulation . 
(13) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(14) Member States should be provided with time to withdraw authorisations for plant  
protection products containing fenamidone.  
(15) For plant protection products containing  fenamidone , where Member States grant any 
grace period in accordance with Article  46 of Regulation (EC) No  1107/2009, th at 
                                                 
6 EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk 
assessment of the active substance fenamidone. EFSA Journal 2016;14(2):4406, 173 pp. 
doi:10.2903/j.efsa.2016.4406 . Available online: www.efsa.europa.eu .  
EN 4  EN period should , at the latest,  expire  on [Office of Publications please insert date 
15 months from the date of entry into force] .  
(16) Commission  Implementing Regulation (EU) 2017/8417 extended  the expiry date of 
fenamidone  to 31 July 2018  in order to allow the renewal process to be completed 
before the expiry of the approval of that substance. However, g iven that a decision is 
taken ahead of th at extended expiry date, this Regulation sh ould apply  as soon as 
possible . 
(17) This Regulation does n ot prevent  the submission of a further application for the 
approval of fenamidone  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 Plant s, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of approval of active substance  
The approval of the active substance fenamidone  is not renewed.   
Article 2 
Amendments to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 62, on 
fenamidone, is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
fenamidone as active substance by [ Office of Publications please insert date 6 months from 
the date of entry into force ] at the latest.  
                                                 
7 Commission Implementing Regulation (EU) 2017/841 of 17 May 2017 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the act ive substances 
alpha -cypermethrin, Ampelomyces quisqualis strain: aq 10, benalaxyl, bentazone, bifenazate, 
bromoxynil, carfentrazone ethyl, chlorpropham, cyazofamid, desmedipham, diquat, DPX KE 459 
(flupyrsulfuron -methyl), etoxazole, famoxadone, fenamidone , flumioxazine, foramsulfuron, 
Gliocladium catenulatum strain: j1446, imazamox, imazosulfuron, isoxaflutole, laminarin, metalaxyl -m, 
methoxyfenozide, milbemectin, oxasulfuron, pendimethalin, phenmedipham, pymetrozine, s -
metolachlor, and trifloxystrobin . (OJ L 125, 18.5.2017, p. 12 .).  
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 [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 i n 
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