EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11600/2016 rev. 1  
[…](2016) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance picoxystrobin, 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 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 picoxystrobin, 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 Implementing Regulation (EU) No 5 40/2011  
(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  79/11 7/EEC and 91/414/EEC1, and in particular 
Article  20(1)  and Article 78 (2) thereof,  
Whereas:  
(1) Commission Directive 2003/84/EC2 included picoxystrobin as 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 picoxystrobin , 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 a pproval of picoxystrobin  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 2003/84/EC of 25 September 2003 amending Council Directive 91/414/EEC to 
include flurtamone, flufenacet, iodosulfuron, dimethenamid -p, picoxystrobin, fosthiazate and silthiofam 
as active substances  (OJ L 247, 30.9.2003, p. 20) . 
3 Counc il 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 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 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 (hereinafter  ‘the Aut hority’) and the Commission on 30 June  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 1 June 2016 the Authority communicated to the Commission its conclusio n6 on 
whether picoxystrobin can be expected to meet the approval criteria provided for in 
Article 4 of Regulation (EC) No 1107/2009. The following concerns were identified: 
health -based reference values for use in risk assessment could not be established a s it was 
not possible to conclude on  the genotoxic  potential of picoxystrobin  based on the 
available data .  Consequently, the consumer and non -dietary risk asessements could not 
be conducted. Furthermore,  a clastogenic and aneugenic potential  of metabolite  IN-
H8612 f ormed  as a residue  cannot be excluded . In addition,  a high risk to aquatic 
organisms and earthworms from exposure to picoxystrobin and a high risk to 
earthworm -eating mammals from exposure to metabolize IN -QDY63 was identified.  
(9) Moreover, a numb er of areas of the assessment could not be finalised. T he compliance of 
the toxicity studies compared to the technical specification and the relevance of 
impurities could not be finalised given that the genotoxic potential of picoxystrobin 
remains inconclu sive. An in vitro  comparative metabolism study was not submitted 
and therefore the possible formation of unique human metabolites is unknown and the 
need for further tests and risk assessment cannot be concluded.  The absence of 
endocrine -mediated effects caused by picoxystrobin could also not be concluded.  
The dietary risk assessment from exposure to metabolites could not be finalised as 
further data are needed to define the toxicological profile of several metabo lites; 
consequently, a residue definition for risk assessment purposes could not be derived.  
Furthermore, the genotoxic potential of several metabolites predicted to occur in 
groundwater could not be concluded based on the data available. Finally, the 
assessment of  the risk from secondary poisoning via the aquatic food chain for birds 
and mammals could not be finalised.  
(10) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority. Furthermore, in accordance with the third paragraph  of Article 14(1) of 
Implementing Regulation (EC) No 844/2012, the Commission invited the applicant to 
submit comments on the draft renewal report. The applicant submitted its comments, 
which have been carefully examined.  
(11) However, despite the argu ments put forward by the applicant, the concerns related to 
the substance  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 criteri a provided for in 
Article 4 are satisfied. The approval of the active substance picoxystrobin  should 
therefore not be renewed . 
                                                 
6 EFSA (European Food  Safety Authority), 2016. Conclusion on the peer review of the pesticide risk 
assessment of the active substance picoxystrobin . EFSA Journal 2016;14( 6):4515, 26 pp. 
doi:10.2903/j.efsa.2016.4 515.  
  
EN 4   EN (13) Commission Implementing Regulation (EU) No 540/2011 should therefore be 
amended accordingly.  
(14) Member States should be allowed sufficient  time to withdraw authorisations for plant 
protection products containing picoxystrobin .  
(15) For plant protection products containing picoxystrobin, 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 [publications office insert date 15  months from 
the date of entry into force] .  
(16) Commission  Implementing Regulation (EU) 2016/9507 extended the expiry date of 
picoxystrobin  to 31  October  2017 in order to allow the renewal process to be 
completed before the expiry of the approval of that substance. Given t hat a decision is 
taken ahead of this 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 picoxystrobin  in accordance with Article 7 of Regul ation (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 approval of active substance  
The approval of the active substance picoxystrobin  is not renewed.   
Article 2 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
picoxystrobin  as active substance by [ Office of Publications please insert date 3 months from 
the date of entry into force ] at the latest.   
Article 3 
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 possib le and shall expire by [insert date 15 months  from the 
date of entry into force]  at the latest.  
                                                 
7 Commission Implementing Regulation (EU) 2016/950  of 15 Ju ne 2016  amending Implementing 
Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 
2,4-DB, beta -cyfluthrin, carfentrazone ethyl, Coniothyrium minitans  Strain CON/M/91 -08 (DSM 9660), 
cyazofamid, deltamethrin,  dimethenamid -P, ethofumesate, fenamidone, flufenacet, flurtamone, 
foramsulfuron, fosthiazate, imazamox, iodosulfuron, iprodione, isoxaflutole, linuron, maleic hydrazide, 
mesotrione, oxasulfuron, pendimethalin, picoxystrobin, silthiofam and trifloxystrobin  (OJ L 159, 
16.6.2016, p.  3).   
EN 5   EN Article 4 
Amendments to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 68, on 
picoxystrobin , is deleted.  
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