EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10238/2020  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance benalaxyl, 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  
concerning the non -renewal of the approval of the active substance benalaxyl, 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 EUROPE AN 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 m arket 
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 2004/58/EC2 included benalaxyl  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 benalaxyl , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011 , expires on 31 July 2021. 
(4) An application for the renewal of the approval of the active substance benalaxyl  was 
submitted in accordance with Articl e 1 of Commission Implementing Regulation (E U) 
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 2004/58/EC of 23 April 2004 amending Council Directive 91/414/EEC to 
include alpha -cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham as 
active substances (OJ L 120, 24.4.2004, p. 26).  
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 an d 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 European Foo d Safety 
Authority ( ‘the Aut hority ’) and the Commission on 12 October  2016 . 
(7) The Authority made the supplementary summary dossier available to the public. The 
Authority also circulated the renewal assessment report to the applicant s and to the 
Member States for comments and launched a publi c consultation on it. The Authority 
forwarded the comments received to the Commission.  
(8) On 19 December 2019 , the Authority communicated  to the Commission its 
conclusion6 on whether benalaxyl  can be expected to meet the approval criteria 
provided for in Arti cle 4 of Regulation (EC) No  1107/2009.  
(9) In its conclusion , the Authority ident ified a number of concerns . In particular,  the 
potential groundwater contam ination by relevant metabolites  could not be excluded.  
Furthermore, a long -term risk to to birds and earthworm -eating birds from secondary 
poisoning from ben alaxyl  was identified as a critical area of concern . Concerns were  also 
identified in relation to the long-term risk to non -target arthropods for all representative 
uses. Finally, following the request by the Authority for additional information  to 
assess  the endocrine disrupting potential of benalaxyl , the applicant confirmed that no 
additional studies would be performed or submitted. Consequently, it cannot be 
concluded that the s ubstance has no endocrine disrupting properties.  
(10) The Commission invited 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 (EU) No  844/2012, the Commission invited the applicant to 
submit comments on the 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 s ubstance  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 approval of the active substance benalaxyl  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 given  sufficient  time to withdraw authorisations for plant 
protection products containing benalaxyl . 
(15) For plant protection products containing benalaxyl , where Member States grant any 
grace period in accordance with Article  46 of Regulation (EC) No  1107/2009, t hat 
period should  not exceed 12 months  from the date of entry into force of this 
Regulation .  
(16) Commission Implementing Regulation (EU) 2020/XXX7 extended the approval period  
of benalaxyl  to 31 July 2021  in order to allow the renewal process to b e completed 
                                                 
6 EFSA (European Food Safety Authority). 20 19. Conclusion on the peer review of the pesticide risk 
assessment of the active substance benalaxyl. EFSA Journal 2020;18(1):5985, 41 pp. 
doi:10.2903/j.efsa.2020.5985.  
7 Commission Implementing Regulation (EU) …/…  (OJ L XX, XX. X.2020, p. XX). EN 3  EN before the expiry of the approval period  of that substance . However, g iven that a 
decision on the non -renewal of the approval is  being taken ahead of the expiry of that 
extended approval period , this Regulation should apply as soon as possible.   
(17) This Regulation does not prevent  the submission of a further application for the 
approval of benalaxyl  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 the approval of the active substance  
The approval of the active substance benalaxyl  is not renewed.   
Article 2 
Amendment  to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 84, on benalaxyl , 
is deleted.  
Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
benalaxyl  as an active substance by  [Office of Publications please insert the date 
corresponding to 6 months from the 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 expire by  [Office of Publications please insert the date corresponding to 
12 months  from the date of entry into force] . 
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  
 Ursula VON DER LEYEN  