EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11216/2016 rev. 1  
[…](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 diflubenzuron  
(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 diflubenzuron  
(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 first 
alterna tive of Article 21(3) and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2008/69/EC2 included diflubenzuron  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) In accordance with Commission Directive 2010/39/EU5, the applicant, at whose 
request diflubenzuron was incl uded in Annex I to Council Directive 91/414/EEC, was 
to provide confirmatory information as regards the potential toxicological relevance of 
the impurity and metabolite 4 -chloroaniline (PCA).  
(4) The applicant submitted that information to the rapporteur Membe r State Sweden  
within the time period provided for its submission.  
(5) Sweden  assessed the 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 Commissio n and the European Food Safety Authority, hereinafter 
‘the Authority’, on 20 December 2011 . 
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2008/69/EC of 1 July 2008 amending Council Directive 91/414/EEC to include 
clofentezine, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram and 
pyriproxyfen as active substances  (OJ L 172, 2.7.2008, p. 9 ). 
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, 11.6.2011, p. 1) . 
5 Commission Directive 2010/39/EU of 22 June 2010 amendi ng Annex I to Council 
Directive  91/414/EEC as regards the specific provisions relating to the active substances clofentezine, 
diflubenzuron, lenacil, oxadiazon, picloram and pyriproxyfen  (OJ L 156, 23.6.2010, p. 7 ).  
EN 3   EN (6) The Commission consulted the Authority , which presented its conclusion on the risk 
assessment of confirmatory information for diflubenzuron on 7  September  20126. The 
Authority communicated its views on diflubenzuron to the applicant , and the  
Commission invited the applicant  to submit its comments on the review report.  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 the Food Chain and Animal Health  and finalised on  16 July 2013 in the format of 
the Commission review report for diflubenzuron.  
(7) Although the results of genotoxicity studies indicate d that P CA is an in vivo  genotoxic 
agent, and PCA is a carcinogenic agent , a genotoxic and carcinogenic potential were 
not observed in studies with an appropriate animal model for human exposure to 
diflubenzuron, and hence to PCA as a metabolite and impurity . In light of the 
information submitted  by the applicant , the Commission considered that the 
confirmatory information required had been provided . 
(8) In its conclusion , given the genotoxic and carcinogenic properties of PCA  and the 
absence of a threshold for accep table exposure , the Authority identified a new concern 
on potential exposure to PCA as a residue.  
(9) The Commission considered that the approval of the active substance diflubenzuron 
should therefore be reviewed in accordance with A rticle 21 of Regulation (EC ) 
No 1107/2009 to address the new concern raised by the Authority. It invited the 
applicant to submit information as regards the potential exposure to PCA  as a residue 
and, if exposure is confirmed, consideration of the potential toxicological relevance.  
(10) The applicant submitted  that information to Sweden within the time period provided 
for its submission.  
(11) Sweden assessed the 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 Authority on 23 July 2014 . 
(12) The Commission consulted the Authority , which presented its conclusion on the risk 
assessment of data submitted for the review of the approval of diflubenzuron on 
11 December  20157. The Authority communicated its views on diflubenzuron to the 
applicant . 
(13) The Commission consider s that the information submitted in the review process  did 
not demonstrate that the risk from the potential exposure of consumers to PCA as a 
residue is acceptab le. In particular, the presence of PCA in the metabolic pathway has 
been demonstrated in some plants and livestock and could not be excluded in others. 
Moreover, studies indicated a significant transformation of diflubenzuron residues into 
PCA under condit ions similar or equal to food sterilisation processes, and such 
transformation could not be excluded for household processing practices.  
(14) Given the genotoxic and carcinogenic properties of PCA and the absence of a 
threshold for acceptable exposure, the revi ew failed to establish that the exposure of 
consumers to PCA as a residue , consequent on application consistent with good plant 
                                                 
6 European Food Safety Authority; Conclusion on the peer review of the p esticide risk assessment of confirmatory 
data submitted for the active substance diflubenzuron . EFSA Journal 201 2;10(9):2870 . [26 pp.] 
doi:10.2903/j.efsa.201 2.2870 . Available online: www.efsa.europa .eu/efsajournal.htm . 
7 European Food Safety Authority; Conclusion on the peer review on the review of the approval of the active 
substance diflubenzuron regarding the metabolite PCA. EFSA Journal 2015;13(8):4222. [30 pp.] 
doi:10.2903/j.efsa.2015 .4222 . Available online: www.efsa.europa.eu/efsajournal.htm .  
EN 4   EN protection practice, has no harmful effects.  Since toxicological reference values for 
PCA cannot be set and as consequently no s afe residue levels can be identified, any 
exposure of consumers to PCA should be prevented.  
(15) The Commission invited the applicant to submit its comments on the review report.  
The comments of the applicant did not alleviate the concerns on consumer safety 
through exposure to PCA.  
(16) The draft assessm ent report, the addend um 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 finalised on  [dd-month -yyyy]  in the format of 
the Commission review report for diflubenzuron.  
(17) The Commission concluded that exposure of consumers to PCA  cannot be excluded 
except by imposing further restrictions . In particular, the use of diflubenzuron  should 
be limited to non -edible cro ps only , and crops treated with diflubenzuron should not 
enter the food and feed chain . In order to minimise the exposure of consumers to PCA, 
it is therefore  appropriate to amend the conditions of  use of diflubenzuron . 
(18) The Annex to Implementing Regulation  (EU) No 540/2011 should therefore be 
amended accordingly.  
(19) Member States should be provided with time to amend or withdraw authorisations for 
plant protection products containing diflubenzuron . 
(20) For plant protection products containing diflubenzuron , where Member States grant 
any grace period in accordance with Article 46 of Regulation (EC) No  1107/2009, that 
period should  expire  at the latest  15 months after the  entry into force  of this Regulation . 
(21) 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  
In the seventh column,  'specific provisions', of entry 174  on diflubenzuron  of Part A of the 
Annex to Implementing Regulation (EU) No 540/2011, the text is replaced by the following:  
"Only uses as  insecticide in non -edible crops  may be authorised.  
For the implementation of the uniform principles as referred to in Article  29(6) of Regulation 
(EC) No  1107/2009, the conclusions of the review report on diflubenzuron , and in particular 
Appendices  I and II thereof, as amended in the Standing Committee on Plants, Animals, F ood 
and F eed on [dd-month -yyyy]  shall be taken into account.  
In this overall assessment Member States  must pay particular attention to:  
– the specification of the technical material as commercially manufactured, which must 
be confirmed and supported by appropriate analy tical data. The test material used in 
the toxicity dossiers shall be compared and verified against this specification of the 
technical material;  
– the protection of aquatic organisms, terrestrial organisms and non -target arthropods 
including bees ; 
– the potent ial unintended exposure of food and feed crops to diflubenzuron  from uses 
on non -edible crops (e.g. through spray drift) ;  
EN 5   EN – the protection  of workers , residents and bystanders . 
Member States shall ensure that crops treated with diflubenzuron do not enter the  food and 
feed chain.  
Conditions of use shall include adequate risk mitigation measures, where appropriate. " 
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 
diflubenzuron  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 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   
 Jean -Claude JUNCKER