EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10802/2018 Rev. 1  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance ethoprophos, 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 Commis sion Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning  the non -renewal of approval of the active substance ethoprophos, 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 Imple menting Regulation (EU) No 540/2011  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
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  79/11 7/EEC and 91/414/EEC1, and in particular 
Article  20(1)  and Article  78(2) thereof,  
Whereas:  
(1) Commission Directive 2007/52 /EC2 included ethoprophos  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 s ubstance ethoprophos , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011 , expires on 31  July 2019 . 
(4) An application for the renewal of the approval of ethoprophos  was submitted in 
accordance with Article 1 of Commission Implementin g 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.  
(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 15 February  2017. 
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 200 7/52/EC of 16 August July 2007  amending Council Directive 91/414/EEC to 
include ethoprophos, pirimiphos -methyl and fipronil  as active substances (OJ L 214, 17.8.2007, 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 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 provi ded 
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 (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 18 May 2018 the Authority communicated to the Commission its conclusion6 on 
whether ethoprophos 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 ethoprophos and therefore health -based reference values 
could not be established. Consequently, the consumer and non -dietary risk asessements 
could not be conduc ted. Furthermore, a high acute risk to birds and a high risk to soil 
dwelling non -target arthropods and soil organisms from the use of ethoprophos were 
identified. In addition, the Authority concluded that several areas of the risk 
assessment could not be finalised including the consumer assessment with respect to 
residues in food of plant and animal origin, the assessment of developmental 
neurotoxicity, the groundwater exposure assessment, the long -term risk to birds , the 
assessment of secondary poisoning for birds and mammals, the risk to soil organisms 
from exposure to metabolites of ethoprophos and the risk to earthworms. Finally, the 
Authority concluded that assessment of the endocrine disrupting potential of 
ethoprophos could not be concluded.  
(10) The Com mission invited the applicant to submit its comments on the conclusion of the 
Authority and, in accordance with the third subparagraph of Article  14(1) of 
Implementing Regulation (EU) No  844/2012, on the draft renewal report. The 
applicant submitted its co mments, 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 representati ve 
uses of at least one plant protection product containing ethoprophos  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 ethopr ophos  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 ethoprophos . 
(15) For plant protection products containing  ethoprophos , where Member States grant any 
grace period in accordance with Article  46 of Regulation (EC) No  1107/2009, th at 
period should , at the latest,  expire  on [Office of Publications please insert date 
12 months  from the date of entry into force] .  
(16) Commission  Implementing Regulation (EU) 201 8/9177 extended  the approval  period 
of ethoprophos  to 31 July 2019  in order to allow th e renewal process to be completed 
                                                 
6 EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk 
assessment of the active substance ethoprophos. EFSA Journal 2018;16(10):5290, 34 pp. 
doi:10.2903/j.efsa.2018.5290. Available online: www.efsa.europa.eu . 
7 Commission Implementing Regul ation (EU) 2018/917 of 27 June 2018 amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 
alpha -cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, EN 3  EN before the expiry of the approval of that substance. However, g iven that a decision  on 
the non -renewal of the approval  is taken ahead of th at extended expiry date , this 
Regulation sh ould apply  as soon as possible . 
(17) This Regulation does not p revent  the submission of a further application for the 
approval of ethoprophos 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 Commi ttee 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 ethoprophos  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 155, on 
ethoprophos , is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
ethoprophos  as active substance by [ Office of Publications please insert date 6 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 possibl e and shall expire by [insert date 12 months  from the 
date of entry into force]  at the latest.  
Article 5  
Entry into force   
This Regulation shall enter into force on the t wentieth  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.  
                                                                                                                                                         
carvone, chlorpropham, cyazofamid, desmedipham, dimethoate, dimethomorph, diquat, ethephon, 
ethoprophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, 
foramsulfuron, formetanate, Gliocladium catenulatum strain:  J1446, isoxaflutole, metalaxyl -m, 
methiocarb, methoxyfenozide, metribuzin, milbemectin, oxasulfuron, Paecilomyces lilacinus strain 251, 
phenmedipham, phosmet, pirimiphos -methyl, propamocarb, prothioconazole, pymetrozine a nd 
s-metolachlor  (OJ L 163, 28.6.2 018, p.  13).  
 EN 4  EN Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER