EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11618/2017 rev 6  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substance mepanipyrim 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)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substance mepanipyrim 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 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 repea ling Council Directives  79/117/EEC and 91/414/EEC1, and in particular 
Article  20(1) thereof,  
Whereas:  
(1) Commission Directive 2004/62/EC2 included mepanipyrim  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 mepanipyrim , as set out in Part  A of the Annex to 
Implementing Regulation (EU) No  540/2011, expires  on 30  April  2019 . 
(4) An application for the renewal of the approval  of mepanipyrim  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 Stat e.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2004/62/EC of 26 April 2004 amending Council Directive 91/414/EEC to 
include mepanipyrim as active substance (OJ L 125, 28.4.2004, p. 38) . 
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 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 Food Safety 
Authority (‘the Authority’) and the Commission on 3 May 2016 . 
(7) The Authority communicated t he 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 s available 
to the public.  
(8) On 15 May 2017 the Authority comm unicated to the Commission its conclusion6 on 
whether mepanipyrim can be expected to meet the approval criteria provided for in 
Article  4 of Regulation (EC) No  1107/2009. The Commission presented the draft 
renewal report for mepanipyrim to the Standing Committee on Plants, Animals, Food 
and Feed on 5  October  2017.  
(9) 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 84 4/2012, on the draft renewal report. The 
applicant submitted its comments, which have been carefully examined.  
(10) It has been established with respect to one or more representative uses of at least one 
plant protection product containing mepanipyrim that the approval criteria provided 
for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore 
appropriate to renew the approval of mepanipyrim.  
(11) The risk assessment for the renewal of the approval of mepanipyrim is based on a 
limited number of representative uses, which, however, do not restrict the uses for 
which plant protection products containing mepanipyrim may be authorised. It is 
therefore appropriate to remove the restriction for use only as a fungicide.  
(12) In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction 
with Article 6 thereof and in the light of current scientific and technical knowledge, it 
is, however, necessary to include certain conditions and restrictions. It is, in particular, 
appropriate to restrict th e use of plant protection products containing mepanipyrim in 
order to minimise the exposure for wild mammals by approving only the use in 
greenhouses and to require further confirmatory information.   
(13) Implement ing Regulation (EU) No 540/2011  should therefor e be amended 
accordingly . 
(14) Commission Implementing Regulation (EU) 2018/5247 extended the expiry date of 
mepanipyrim  to 30 April  2019 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 this extended expiry date, this Regulation should apply from 
1 March  2019. 
                                                 
6 EFSA (European Food Safety  Authority), 2017. Conclusion on the peer review of the pesticide risk 
assessment of the active substance mepanipyrim. EFSA Journal 2017;15(6):4852 [22 pp.]. doi: 
10.2903/j.efsa.2017.4852 . 
7 Commission Implementing Regulation (EU) 2018/524 of 28 March 2018  amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 
Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, clopyralid, 
cyprodinil, dichlorprop -P, fose tyl, mepanipyrim, metconazole, metrafenone, pirimicarb, Pseudomonas 
chlororaphis strain: MA 342, pyrimethanil, quinoxyfen, rimsulfuron, spinosad, thiacloprid, 
thiamethoxam, thiram, tolclofos -methyl, triclopyr, trinexapac, triticonazole and ziram ( OJ L 88, 
4.4.2018, p.  4).  
EN 3  EN (15) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and F eed, 
HAS ADOPTED THIS REGULATION:  
Article 1  
Renewal of approval of active substance  
The approval of the active substance mepanipyrim is renewed as set out in Annex I.   
Article 2  
Amendments to Implementing Regulation (EU) No 540/2011  
The Annex to Implementi ng Regulation (EU) No 540/2011 is amended in accordance with 
Annex II to this Regulation.   
Article 3 
Entry into force and date of application  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from 1 March  2019.  
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