EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10724/2020 rev. 1Final  
[…](2021) XXX  draft 
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulations (EU) No 2015/1295 and No 540/2011 as regards the 
conditions of approval of the active substance sulfoxaflor  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulations (EU) No 2015/1295 and No 540/2011 as regards the 
conditions of approval of the active substance sulfoxaflor  
(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 
Counci l 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 first 
alternative of Article 21(3) and Article 78(2) thereof,  
Whereas:  
(1) Commission Impl ementing Regulation (EU) No 2015/12952 provides for the approval 
of the active substance sulfoxaflor  and the resulting insertion of sulfoxaflor  in the 
Annex to Commission Implementing Regulation (EU) No 540/20113. 
(2) Implementing Regulation (EU) No 2015/1295  also provides for the submission of 
further confirmatory information on the risk to honey bees via the different routes of 
exposure, in particular nectar, pollen, guttation fluid and dust , the risk to honey bees 
foraging for nectar or pollen in succeeding  crops and flowering weeds , the risk to 
pollinators other than honey bees and the risk to bee brood.  
(3) The applicant  submitted the required confirmatory information within the period 
provided for in Implementing Regulation (EU) No 2015/1295 . 
(4) As agreed between Ireland and the Czech Republic, the rapporteur  and the co -
rapporteur  Member State , the Czech Republic  assessed the confirmatory information 
submitted by the applicant . The Czech Republic submitted its assessment, in the form 
of an addendu m to the draft assessment report, to the other Member States, the 
Commission, and the European Food Safety Authority (‘the Authority’ ) on 
12 March  2018 .  
(5) The Member States, the applicant and the Authority were consulted and asked to 
provide comments on the  assessment  of the confirmatory info rmation  by the co-
rapporteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p. 1 . 
2 Commission Implementing Regulation (EU) 2015/1295 of 27 July 2015 approving the active substance 
sulfoxaflor, 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 199, 29.7.2015, p. 8 ). 
3 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 1 53, 11.6.2011, p. 1).  EN 2  EN (6) The Authority published a technical report4 summarising the outcome of this 
consultation for sulfoxaflor on 20 September  2018 .  
(7) As divergent opinions were expressed during  the consultation on the addendum to the 
draft assessment report , the Commission consulted the Authority  and requested it to 
provide a conclusion on all points where there w ere divergen t opinion s.   
(8) The Authority  published  its conclusion on the risk assessment on 28 March  20195. The 
Commission further consulted the Authority in relation to the risk to bees .  The 
Commission asked the Authority, particular , to complete the assessment of the spray 
drift reducing measures necess ary to protect bumblebees and solitary bees  in field 
margins from exposure to sulfoxaflor  and of the risk to bees from puddle water .  
(9) The Authority  published its updated conclusion on 30 March  20206. 
(10) In its updated conclusion, t he Authority considered  that in the light of the outcome of 
the evaluation of the confirmatory information provided by the applicant , the risk to 
bees for uses in permanent greenhouses  was acceptable . However , the assessment of 
the risk to bumble bees and solitary bees  from outdo or uses could not be finalised . 
Therefore, the Authority could not conclude that there is a low risk to bumble bees and 
solitary bees from outdoor uses .  
(11) The draft assessment report, the addendum and the updated conclusion of the 
Authority were reviewed by the Member States and the Commission within the 
Standing Committee on Plants, Animals, Food and Feed and finalised on 28 January  
2022. At the same time, the review report for sulfoxaflor  was updated .  
(12) The applicant was giv en the possibility to submit comments on the updated review 
report.  
(13) However, despite the arguments put forward by the applicant, the Commission has 
concluded that a risk to bees from outdoor uses of sulfoxaflor cannot be excluded. 
Consequently, in accordan ce 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 sulfoxaflor to uses in permanent greenhouses only.  
(14) Implementing Regulation s (EU) No 2015/1295  and (EU) No 540/2011 should 
therefore be amended accordingly.  
(15) Member States should be allowed sufficient  time to withdraw or amend  authorisations 
for plant protection products containing sulfoxaflor that do not comply with the 
restricted conditions of approval.  
(16) For plant protection products containing sulfoxaflor , where Member States grant a 
grace period in accordance with Article  46 of Regulation (EC) No  1107/2009, that 
period should be as short as possible  and expire no later than  12 months after the entry 
into force of this Regulation.  
                                                 
4 EFSA (European Food Safety Authority), 201 8. Technical report on the outcome of the consultation 
with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of 
confirmatory data . EFSA support ing publication 201 8:EN-1474 . 73 pp. 
5 EFSA (European Food Safety Authority), 2019. Conclusion on the peer review of the pesticide risk 
assessment for the active substance sulfoxaflor in light of confirmatory data submitted. EFSA Journal 
2019;17(3):5633, 14 pp.  
6 EFSA (European Food Safety Authority), 2020. Conclusion on the peer review of the pesticide risk  
assessment for the active substance sulfoxa flor in light of confirmatory data submitted. EFSA Journal  
2020;18(3):6056, 15 pp .  EN 3  EN (17) In light of all the available pertinent information, it is considered inappropriate to 
maintain the approval of the active substance for outdoor use at this time. However, 
this Regulation does not prevent the applicant  from submi tting additional information  
to amend the conditions of approval , as provided in Articles 7 and 14 of Regulation 
(EC) No 1107/2009, and that information will be reviewed within a reasonable period 
of time as provided for  in that Regulation.  
(18) The measures pr ovided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Amendment to Implementing Regulation (EU) No 2015/1295  
Annex I to Implementing Regulation ( EU) No 2015/1295  is amended in accordance with 
Annex I to this Regulation.  
Article 2 
Amendment to 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 sulfoxaflor  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 Member States in accordance with Article 46 of Regulation (EC) 
No 1107/2009 shall expire by … [Office of Publications  please 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 appl icable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  EN 4  EN  Ursula VON DER LEYEN