EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11618/2017  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance mepanipyrim, in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council, and amending Commission Implementing Regulation (EU) No  540/2011  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance mepanipyrim, in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council, and amending Commission Implementing Regulation (EU) No  540/2011  
(Text with EEA r elevance)  
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 protecti on 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  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 Impl ementing 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 15 March  2025.  
(4) An application for the renewal of the approval of the active  substance mepanipyrim 
was submitted to Belgium , the rapporteur Member State, and Greece , the co -
rapporteur Member State, in accordance with Article 1 of Commission Implementing 
Regulation (EU) No 844/20125 within the time period provided for in that Arti cle. 
(5) The applicant submitted the supplementary dossiers required to the rapporteur 
Member State, the co -rapporteur Member State, the Commission and the European 
Food Safety Authority (‘the Authority’) 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 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 produc ts 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 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 Authority and the 
Commi ssion on 3 May 2016. In its draft renewal assessment report the rapport eur 
Member State proposed to renew the approval of mepanipyrim.  
(7) The Authority made the supplementary summary dossier available to the public. The 
Authority also circulated the renewal a ssessment report to the applicant  and to the 
Member States for comments and launched a public consultation on it. The Authority 
forwarded the comments received to the Commission.  
(8) On 12 May 2017, the Authority communicated 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.  
(9) The Commission presented an initial draft renewal report for mepanipyrim to the 
Standing Committee on Plants, Animals, Food an d Feed on 5 October 2017.  
(10) In accordance with Article 14(1a) , first subparagraph,  of Implementing Regulation 
(EU) No 844/2012, the Commission requested  the Authority to reasse ss the available 
information on endocrine disrupting properties  of the active substance .  
(11) On 14 July  2023, the Authority communicated to the Commission its updated 
conclusion7 on whether mepanipyrim can be expected to meet the approval criteria 
provided for in Article 4 of Regulation (EC) No 1107/2009 including its finalised 
assessment of endocrine disrupting properties.  
(12) The Authority identified certain specific concerns. In particular, it concluded that 
mepanipyrim is considered to meet the criteria for endocrine disruptors for humans 
and wild mammals as non -target organisms set out in  points 3.6.5 and 3.8.2 of Annex 
II to Regulation (EC) No 1107/2009 , due to its  oestrogen, androgen and 
steroidogenesis  (EAS )-modalities . Negligible exposure  of humans  to mepanipyrim 
cannot be demonstrated since residues above the defau lt value of 0.01 mg/kg are 
expected to occur. Therefore, the requirements set out in point 3.6.5 and 3.8.2 of 
Annex II to Regulation (EC) No 1107/2009 are not fulfilled. Additionally, a high long -
term risk was identified for wild mammals exposed to mepanip yrim via dietary 
exposure, for all representative uses.  Furthermore, several issues could not be 
finalised, including  the consumer risk assessment.  
(13) Article 4(7) of Regulation (EC) No 1107/2009 provides for the possibility of a 
restricted approval of substances identified as endocrine disruptors if it can be 
demonstrated that the active substance is necessary to control a serious danger to plant 
health which cannot be contained by other available means including non -chemical 
methods. As the applicant did not provide any information to demonstrate such 
necessity, this derogation cannot be considered.  
(14) The Commission presented an updated draft renewal report for mepanipyrim to the 
Standing Committee on Plants, Animals, Food and Fe ed on 12 October 2023.  
(15) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority. Furthermore, in accordance with Article 14(1), third subparagraph, of 
 
6 EFSA (European Food Safety Authority), 201 7. 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 EFSA (European Food Safety Authority), 20 23. Updated conclusion on the peer review of the pesticide 
risk assessment of the  active substanc e mepanipyrim . EFSA Journal, 21(8), 1 –26. 
doi.org/10.2903/j.efsa.2023.8196 .  
EN 3  EN Implementing Regulation (EU) No 844/2012, the Commission invited th e applicant to 
submit comments on the renewal report. The applicant submitted its comments, which 
have been carefully examined.  
(16) Despite the arguments put forward by the applicant, the concerns regarding the active 
substance could not be eliminated.  
(17) Conseq uently, 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 mepanipyrim . 
(18) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(19) Member States should be given sufficient time to withdraw authorisations for plant 
protection products containing mepanipyrim . 
(20) For plant protection products containing mepanipyrim , where Member States grant 
any grace period in accordance with Article 46 of Regulation (EC) No  1107/2009, that 
period should not exceed 12 months from the date of entry into force of this 
Regulation.  
(21) Commission Implementing Regulation (EU) 2023/689 of 20 March 20238 extended 
the period of approval of mepanipyrim until 15 March 2025 in order to allow the 
renewal process to be completed before the expiry of the approval period of that 
substan ce. However, given that a decision on the non -renewal of the approval is taken 
ahead of the expiry of that extended approval period, this Regulation should apply 
earlier than that date.  
(22) This Regulation does not prevent the submission of a further applicati on for the 
approval of mepanipyrim pursuant to Article  7 of Regulation (EC) No  1107/2009.  
(23) 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 REGULATI ON: 
Article 1  
Non-renewal of approval of active substance  
The approval of the active substance mepanipyrim  is not renewed.  
 
8 Commission Implementing Regulation (EU) 2023/689 of 20  March 2023 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, Bacillus thuringiensis subsp. Aizawai strains ABTS -1857 
and GC -91, Bacillus thuringiensis subsp. Israeliensis (serotype H -14) strain AM65 -52, 
Bacillus  thuringiensis subsp. Kurstaki strains ABTS 351,  PB 54, SA 11, SA12 and EG  2348, Beauveria 
bassiana strains ATCC 74040 and GHA, clodinafop, Cydia  pomonella Granulovirus (CpGV), 
cyprodinil, dichlorprop -P, fenpyroximate, fosetyl, malathion, mepanipyrim, metconazole, metrafenone, 
pirimicarb, pyridaben, pyr imethanil, rimsulfuron, spinosad, Trichoderma asperellum (formerly T. 
harzianum) strains  ICC012, T25 and TV1, Trichoderma atroviride (formerly T. harzianum) strain  T11, 
Trichoderma gamsii (formerly T. viride) strain ICC080, Trichoderma  harzianum strains T -22 and 
ITEM  908, triclopyr, trinexapac, triticonazole and ziram  (OJ L 91, 29.3.2023, p. 1 ).  
EN 4  EN Article 2  
Amendment to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011  the entry  on 
mepanipyrim is deleted.  
Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
mepanipyrim  as an active substance by … [ Office of Publications please insert date 6 months 
from the date of entry into force of this Regulation ]. 
Article 4  
Grace period  
Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) 
No 1107/2009 shall expire by … [Offi ce of Publications please insert date 12 months from 
the date of entry into force of this Regulation] . 
Article 5  
Entry into force  
This Regulation shall enter into force on 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 t he Commission  
 The President  
 Ursula VON DER LEYEN