EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10626/2017 rev 1  
[…](2017) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance iprodione, 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 
Commissi on 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 iprodione, 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 Implementing 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 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 2003/31 /EC2 included iprodione  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 Imple menting Regulation (EU) No 540/20114. 
(3) The approval of the active substance iprodione , as set out in Part  A of the Annex to 
Implementing Regulation (EU) No  540/2011 , expires on 31 October  2017 . 
(4) An application for the renewal of the approval  of iprodione  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 2003/31/EC of 11 April 2003 amending Council Directive 91/414/EEC to 
include 2,4 -DB, beta -cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin as 
active substances  (OJ L 101, 23.4.2003, p. 3 ). 
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 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 p rovided 
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 Foo d Safety 
Authority (‘the Authority’) and the Commission on 3 November  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 8 June 2016  the Authority communicated to the Commission its conclusion6 on 
whether iprodione  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 relevant metabolites of 
iprodione in situations repre sented by all pertinent groundwater scenarios ; one relevant 
metabolite is even predicted to e xceed 0.75  μg/l in all pertinent groundwater scenarios . In 
addition , the Authority also concluded that there is a high long -term risk to aquatic 
organisms.  
(9) Furthermore, in respect of  one metabolite , found as a residue in plants and as an impurity 
in the technical material,  the Authority concluded that the genotoxic potential  cannot be 
excluded and the refore the  setting of reference values for that  metabolite cannot be 
confirmed based on the information available . Moreover, based on the available 
information, the the dietary risk assessment could not be ﬁnalised  as it is not possible to 
establish residue definitions for risk assessment, nevertheless , an acute  consumer risk 
could not be excluded. Finally, the long -term risk assessment for wild mammals for all 
the relevant routes of exposure could not be ﬁnalised , based on the information  submitted 
in the dossier . 
(10) Additionally, iprodione is classified as carcino gen category 2 in accordance with 
Regulation (EC) No  1272/2008 of the European Parliament and of the Council7 and in 
the conclusion of the Authority it is indicated that during the peer review it was 
proposed that iprodione should be re-classified as carci nogen category  1B and as toxic 
for reproduction category  2. 
(11) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority  and, in accordance  with the third paragraph  of 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, despite the arguments put forward by the applicant, the concerns related to 
the substance could not be eliminated.  
(13) Based on the  risks  identified, 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 
appropriat e not to renew the approval of iprodione in accordance with Article  20(1)(b) 
of that Regulation.  
                                                 
6 EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide ri sk 
assessment of the active substance iprodione. EFSA Jour nal 2016;14(11):4609, 31 pp. 
doi:10.2903/j.efsa.2016.4609.  
7 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classificatio n, 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 (14) Member States should be given  time to withdraw authorisations for plant protection 
products containing iprodione .  
(15) For plant protection products containing ipr odione, where Member 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] .  
(16) Commiss ion Implementing Regulation (EU) 2017/XXX8 extended the expiry date of 
iprodione  to 31 October  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 has 
been taken ahead of that extended expiry date, this Regulation sh ould apply  as soon as 
possible .  
(17) This Regulation does not prejudice the submission of a further application for the 
approval of iprodione  pursuant to Article 7 of Reg ulation (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 a pproval of the active substance iprodione  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 50, on iprodione, 
is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
iprodione  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 15 months from the date of entry into force ] at the latest.  
                                                 
8 Commission Implementing Regulation (EU) 201 7/XXX  amending Implementing Regulation (EU) No 
540/2011 as regards the extension of the approval periods of the active substances 1 -
methylcyclopropene, 2,4 -DB, beta -cyfluthrin, chlorothalonil, chlorotoluron, cypermethrin, daminozide, 
deltamethrin, dimethenamid -p, flufenacet, flurtamone, forchlorfenuron, fosthiazate, indoxacarb, 
iprodione, maleic hydrazide, MCPA, MCPB, silthiofam, thiophanate -methyl and tribenuron () 
  EN 5   EN 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