EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10311/2016 rev. 0  
[…](2016) 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 buprofezin  
(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 buprofezin  
(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 79/117/EEC and 91/414/EEC1, and in particular the second 
alternative of Article  21(3)  and Article 7 8(2) thereof , 
Whereas:  
(1) Commission Directive 2011/6/EU2 included buprofez in as active substance in Annex  I 
to Council Directive 91/414/EEC3, under the condition that the Member States 
concerned ensure that the notifier , at whose request buprofezin was included in that 
Annex , provides further confirmatory information as regards the processing and 
conversion factors for consumer risk assessment.  
(2) Active substances included in Annex I to Directive 91/414/EEC are deemed to h ave 
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) On 30 January 2013 , the applicant submitted additional information concerning the 
processing and conversion factors to the rapporteur Member State United Kingdom 
within the time period provided for its submission.  
(4) The United Kingdom 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, 
hereinafter ‘the Authority’, on 9 September 2014.  
(5) The Commission consulted the Authority which presented its conclusion  on the risk 
assessment of buprofezin  on 28 July 20155. The draft assessment report, the addendum 
and the conclusion  of the Authority were reviewed by the Member States and the 
Commission within the Standing Committee on Plants, Animals, Food and Feed and 
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2011/6/EU of 20  January 2011 amending Council Directive 91/414/EEC to 
include buprofezin as active substance  (OJ L 18, 21.1.2011, p. 38 ). 
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, 1 1.6.2011, p. 1). 
5 Conclusion on the peer review of the pesticide risk assessment for the active substance buprofezin in 
light of confirmatory data . EFSA Journal 2015; 13(8): 4207 , 24 pp. doi: 10.2903/j.efsa. 2015/4207 .  EN 3   EN finalised on  24 January 2017  in the format of the Commission review report for 
buprofezin .  
(6) The Commission invited the applicant to submit its comments on the review report for 
buprofezin.  
(7) The Commission has considered that the additional  information provid ed showed  that 
under high temperature processing conditions buprofezin is degraded into several 
metabolites , including aniline. Aniline is a carcinogen for which a genotoxic 
mechanism cannot be excluded and therefore no threshold for acceptable exposure can 
be assumed.  
(8) The Commission has concluded that the further confirmatory information required has 
not been fully provided and that exposure of consumers to aniline via consumption of 
processed crops cannot be excluded except by imposing further restrictions . In 
particular, the use of buprofezin should be limited to non -edible crops only.  
(9) It is confirmed  that th e active substance buprofezin is to be deemed to have been 
approved under Regulation (EC) No 1107/2009 . In order to minimise the exposure of 
consumers to aniline, it is, however , appropriate to amend the conditions of  use of this 
active substance.  
(10) The Anne x to Implementing Regulation (EU) No 540/2011 should therefore be 
amended accordingly.  
(11) Member States should be provided with time to amend or withdraw authorisations for 
plant protection products containing buprofezin . 
(12) For plant protection products contain ing buprofezin , 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 [Office of Publications please insert date 15 months  from 
the date of entry into force] . 
(13) The measures provided 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 (EC) No 540/2011  
The Annex to Implement ing Regulation (EU) No 540/2011 is amended in accordance with the 
Annex to this Regulation.  
Article 2  
Transitional measures  
Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary 
amend or withdraw existing authorisations for plant protection products containing buprofezin  
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 int o 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