EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10657/2017 rev. 1  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulations (EU) No 22/2013 and No 540/2011 as regards the 
conditions of approval of the active substance cyflumetofen  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulations (EU) No 22/2013 and No 540/2011 as regards the 
conditions of approval of the active substance cyflumetofen  
(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 
Counc il of 21 October 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 I mplementing Regulation (EU) No 22/20132 provides for the approval of 
the active substance cyflumetofen and the resulting insertion of cyflumetofen in the 
Annex to Commission Implementing Regulation (EU) No 540/20113. Implementing 
Regulation (EU) No 22/2013  also provides for the submission of further confirmatory 
information on the mutagenic potential of metabolite  B3 and the dietary exposure 
thereof and on the risk from cyflumetofen to aquatic vertebrates.  
(2) The applicant  submitted additional information with a view to rule out  the mutagenic 
potential of metabolite  B3 and to confirm an acceptable risk for aquatic vertebrates.  
(3) The Netherlands assessed the additional information submitted by the applicant . It 
submitted its assessment, in the form of an addendum to the draft assessment report, to 
the other Member States, the Commission, and the European Food Safety Authority 
(‘the Authority’ ) on 6 October  2015.   
(4) The Member States, the applicant and the Auth ority were consulted and asked to 
provide comments on the assessment of the rapporteur Member State. The Authority 
published a Technical Report4 summarising the outcome of this consultation for 
cyflumetofen on 25 February 2016 . 
                                                 
1 OJ L 309, 24.11.2009, p. 1 . 
2 Commission Implementing Regulation (EU) No 22/2013  approving the active substance cyflumetofen, 
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  (OJ L 11, 16.1.2013, p. 8.).  
3  Commission Implemen ting 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).  
4  EFSA (European Food Safety Authority),  2016. Technical report on the outcome of the consultation 
with Member States, the applicant and EFSA on the pesticide risk assessment of confirmatory data  for 
cyflumetofen in light of confirmatory data . EFSA supporting publication 2016:EN -997. 25 pp.  EN 2  EN (5) The Commission further consu lted the Authority in relation to the assessment of 
metabolite B3. The Authority published  its Conclusion5 on the assessment of  the 
additional information  on 5 December  2016.   
(6) The Authority considered that according to the additional information provided b y the 
applicant , an acceptable risk to aquatic vertebrates is confirmed on a life -cycle basis. 
Point (c) in the Annex to Regulation (EU) No 22/2013 should hence be considered 
addressed.  However , concerning  metabolite  B3, a genotoxic potential  could not be 
excluded  from the additional  data submitted  in accordance with point s (a) and (b) of 
the Annex to Regulation (EU) No 22/2013 .  
(7) The draft assessment report, the addendum and the conclusion  of the Authority were 
reviewed by the Member States and the Commissi on within the Standing Committee 
on Plants, Animals, Food and Feed  and finalised on XX XXXX  2019 in the format of 
the Commission review report for cyflumetofen .  
(8) The applicant was given the possibility to submit comments on the updated review 
report.  
(9) The C ommission has conlcuded that the additional information provided is not 
sufficient to exclude the genotoxic potential of metabolie B3  and that the conditions of 
approval set out in the Annex to  Commission Implementing Regulation (EU) No 
540/20116 should be restricted  to ensure that the use of products containing 
cyflumetofen is acceptable, in particular concerning the exposure of groundwater to 
metabolite  B3.  
(10) Therefore i n accordance with Article  21(3) of Regulation (EC) No  1107/2009 in 
conjunction  with Article  6 thereof, it is necessary and appropriate to restrict the 
approval of cyflumetofen.  
(11) Implementing Regulation s (EU) No 22/2013 and (EU) No 540/2011 should therefore 
be amended accordingly.  
(12) Member States should be provided with time to amend or  withdraw authorisations for 
plant protection products containing cyflumetofen which are not complying with the 
restricted conditions of approval.  
(13) For plant protection products containing cyflumetofen, where Member States grant 
any grace period in accordan ce with Article  46 of Regulation (EC) No  1107/2009, this 
period should expire at the latest 12 months after the entry  into force of this 
Regulation.  
(14) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee o n Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Amendment to Implementing Regulation (EU ) No 22/2013  
Annex I to Implementing Regulation (EU) No 22/2013 is amended in accordance with Annex 
I to this Regulation.  
                                                 
5 EFSA Journal 2016;14(12):4635, available online: www.efsa.europa.eu  
6  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).  EN 3  EN Article 2 
Amendment t o Implementing Regulation (EU) No 540/2011  
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the 
Annex II to this Regulation.  
Article 3 
Transitional measures  
Member States shall, where necessary, withdraw  or amend authorisations for plant protection 
products containing cyflumetofen as active substance by [ Office of Publications please insert 
date 6 months  after date of entry into force ] at the latest . 
Article 4 
Grace period  
Any grace period granted by Memb er States in accordance with Article 46 of Regulation (EC) 
No 1107/2009 shall be as short as possible 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 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