EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10424/2020  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of 
approval of the active substance fenpyrazamine  
(Text with EEA relevance)   EN 2  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of 
approval of the active substance fenpyrazamine  
(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 Oc tober 2009 concerning the placing of plant protection products on the market 
and repealing Council Directives 79/117/EEC and 91/414/EEC1, and in particular the second 
alternative of Article 21(3)  and Article 78(2) thereof , 
Whereas:  
(1) Commission Implementing Regulation (EU) No 595/20122 approved  fenpyrazamine  
as an active substance in accordance with Regulation (EC) No 1107/2009  subject to 
certain conditions , requiring , in particular,  the examining Member State to inform the 
Commission in accordan ce with Article 38 of Regulation (EC) No 1107/2009 on the 
specification of the technical material as commercially manufactured.  
(2) In December 2013 , the applicant submitted an updated dossier intended to provide the 
information on specification of the technic al material as commercially manufactured  
to the  rapporteur Member State Austria  within the time period provided for its 
submission . The updated dossier was evaluated by the rapporteur Member State in the 
form of an Addendum to the Draft Assessment Report.  
(3) On 23 April 2014, Austria  distributed the addendum to the Member States, the 
applicant and the European Food Safety Authority  (‘the Authority’ ) for comments, 
collated together with all comments in the format of a reporting table, which was 
submitted to the Authority  on 7 July 2014.  The Authority  added its scientific views on 
the specific points raised during the comm enting phase in the reporting table.  
(4) On 13 August 2014, t he Authority published  a technical report3 summarising the 
outcome of this consultation  process for fenpyrazamine .  
(5) The draft assessment report, the addendum and the technical report were reviewed by 
the Member States and the Commission within the Standing Committee on Plants, 
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Implementing Regulation (EU) No 595/2012 of 5 July 2012 approving the active 
substance fenpyrazamine, 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 m arket, and 
amending the Annex to Commission Implementing Regulation (EU) No 540/2011  (OJ L 176, 6.7.2012, 
p. 46 ). 
3 EFSA (European Food Safety Authority), 2015. Outcome of the consultation with Member States, the 
applicant and EFSA on the pesticide risk as sessment of confirmatory data for the active substance 
fenpyrazamine . EFSA supporting publication 2014:EN -630. EN 3  EN Animals, Food and Fe ed and finalised on  18 May 2020  in the format of the 
Commission review report for fenpyrazamine .  
(6) The Commission invited the applicant to submit its comments on the Commission 
review report for fenpyrazamine . 
(7) In its review report t he Commission considered that the  technical specification  
proposed in the approval  of fenpyrazamine needs to be change d from pilot to 
commercial production. The impurity hydrazine, a starting material, has been 
identified during the assessment as a relevant impurity , since it was detected  in the 
reanalysed pilot plant batches as well as in the commercial plant batches . Bearing in 
mind that the relevant impurity  hydrazine is of toxicological concern , the Commission 
has concluded  that a maximum content of  this impurity  in the technic al material 
should not exceed 0.0001% (1 mg/kg) . 
(8) In order to ensure a high level of protection for consumers it is, therefore, appropriate 
to establish a  maximum level for this impurity in the commercially manufactured 
active substance .  
(9) The Annex to Imple menting Regulation (EU) No 540/2011 should therefore be 
amended accordingly.  
(10) Member States should be allowed sufficient  time to amend or withdraw authorisations for 
plant protection products containing fenpyrazamine , which are not complying with the 
specification of the technical material as commercially manufactured and the restricted 
conditions of approval . 
(11) For plant protection products containing fenpyrazamine , where Member States grant 
any grace period in accordance with Article 46 of Regulation ( EC) No 1107/2009, th at 
period should  expire , at the latest, 15 months after the entry into force of this 
Regulation.  
 
(12) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Fee d, 
HAS ADOPTED THIS REGULATION:  
Article 1 
Amendment to Implementing Regulation (E U) No 540/2011  
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the 
Annex to this Regulation.  
Article 2  
Transitional measures  
Member States  shall, where necessary , amend or withdraw existing authorisations for plant 
protection products containing fenpyrazamine  as active substance by … [Office of 
Publications please insert date 3 months  from the date of entry into force ] at the latest.  EN 4  EN 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 possible and shall expire by [Office of Publications please 
insert date 15  months from the date of entry into force] at the latest.   
Article 4 
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