EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10154/2020 Rev 1  
[…](2019) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance bromoxynil, 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  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance bromoxynil, 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  
(Text with EEA relevance)  
THE EUROP EAN 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  79/11 7/EEC and 91/414/EEC1, and in particular 
Article  20(1)   and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2004/58 /EC2 included  bromoxynil  as an 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) The approval of the active su bstance bromoxynil , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011 , expires on 31 July 2020.  
(4) An application for the renewal of the approval of the active substance bromoxynil  was 
submitted in accordance with Article 1 of Commission Implementing Regulation (E U) 
No 844/20125 within the time period provided for in that Article.  
(5) The applicant submitte d the supplementary dossiers required in accordance with 
Article 6 of Implementing Regulation (EU) No 844/2012. The application was found 
to be complete by the rapporteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2004/58/EC of 23 April 2004 amending Council Directive 91/414/EEC to 
include alpha -cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham as 
active substances  (OJ L 120, 24.4.2004, p.  26). 
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 Implementing Regulation (EU) No 844/2012 of 18 Septe mber 2012 setting out the 
provisions necessary for the implementation of the renewal procedure for active substances, as provided 
for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the 
placing of plant protection p roducts on the market (OJ L 252, 19.9.2012, p. 26).  EN 2  EN (6) The rapporteur Member State prepared a  renewal assessment report in consultation 
with the co -rapporteur Member State and submitted it to the European Foo d Safety 
Authority ( ‘the Aut hority’) and the Commission on 21 March 2016.  
(7) The Authority made the supplementary summary dossier available to the public. The 
Authority also circulated the renewal assessment report to the applicant and to the 
Member States for comments and launched a pu blic consultation on it. The Authority 
forwarded the comments received to the Commission.  
(8) On 10 Aril 2017,  the Authority communicated  to the Commission its conclusion6 on 
whether bromoxynil can be expected to meet the approval criteria provided for in 
Article 4 of Regulation (EC) No 1107/2009.  
(9) The conclusion of the Authority indicates that , during the peer review , experts from 
Member States and the Authority suggested that bromoxynil, currently subject to 
harmonised classification and labelling in accor dance with Regulation (EC) 
No 1272/20087 as toxic for reproduction category  2, should be classified as toxic for 
reproduction category 1B in accordance with the criteria laid down in that Regulation. 
The Commission therefore requested the Authority to conside r whether negligible  
exposure in accordance with Point  3.6.4 of  Annex II to Regulation (EC) No  1107/2009 
could be demonstrated. On 8 November 2018, the Authority communicated to the 
Commission its conclusion8 that, for the representative uses con sidered, non -dietary 
exposure to bromoxynil cannot  be considered negligible.  In that conclusion the 
Authority identified a risk to child residents from the representative uses of bromoxynil 
even when taking into account available mitigation measures.    
(10) In its conclusion from 2017 , the Authority also identified a high risk to wild mammals 
from dietary exposure to bromoxynil . Furthermore, the Authority concluded that the 
consumer risk assessment for products of animal origin and the risk assessment for 
aquati c organisms could not be finalised . 
(11) In its Scientific Report9 the Authority concluded that although for some uses of 
bromoxynil and in some Member States there may be an insufficient number of 
chemical alternatives available, a wide range of preventive and  curative non -chemical 
methods are available, and that a combination of chemical and non -chemical methods 
appears often possible. Given the above -mentioned concerns, in particular the risk to 
child residents, and the existence of alternatives, which would allow the application of 
the principles of integrated pest management, as provided for in Article 55 of 
Regulation (EC) No 1107/2009, the conditions for the application of the derogation in 
Article 4(7) of Regulation (EC) No 1107/2009, which are cumulative , are not fulfilled.  
                                                 
6 EFSA (European Food Safety Authority), 2017. Conclusion on the peer review of the pesticide risk 
assessment of the active substance bromoxynil (variant evaluated bromoxynil octanoate). EFSA Journal 
2017 ;15(6):4790, 24 pp. https://doi.org/10.2903/j.efsa.2017.4790 . 
7 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packagi ng of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907 /2006 (OJ L 353, 31.12.2008, 
p. 1). 
8 EFSA (European  Food  Safety  Authority),  2018.  Conclusion  on the peer review  of the pesticide  risk 
assessment for  the active  substance  bromoxynil  in light of negligible  exposure  data submitted.  EFSA  
Journal 2018;16 (12):5490,  15 pp. https://doi.org/10.2903/j.efsa.2018.5490 . 
9  EFSA (European Food Safety Authority), 2018. Scientiﬁc report on evaluation of data concerning the 
necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be 
contained by other available means, including non -chemical m ethods. EFSA Journal 2018;16(8):5391, 
80 pp. https://doi.org/10.2903/j.efsa.2018.5391  EN 3  EN (12) The Commission invited the applicant to submit its comments on the conclusion s of 
the Authority. Furthermore, in accordance with the third subparagraph of  Article  14(1) 
of Implementing Regulation (EU) No  844/2012, the Commission invited the applicant 
to submit comments on the renewal report. The applicant submitted its comments, 
which have been carefully examined.  
(13) However, despite the arguments put forward by the applicant, the concerns regarding 
the active substance  could not be eliminated.  
(14) Consequently, it has not been  established with respect to one or more representative 
uses of at least one plant protection product that the approval criteria provided for in 
Article 4 of Regulation (EC) No  1107/2009 are satisfied. It is theref ore appropriate not 
to renew the approval of the active substance bromoxynil in accordance with 
Article  20(1)(b) of that Regulation . 
(15) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(16) Member States should be given  sufficient  time to withdraw authorisations for plant 
protection products containing bromoxynil . 
(17) For plant protection products containing bromoxynil where Member States grant any 
grace period in accordance with Article  46 of Regulation (EC) No 1107/2009, t hat 
period s hould  not exceed 12 months  from the date of entry into force of this 
Regulation .  
(18) This Regulation does not prevent  the submission of a further application for the 
approval of bromoxynil  pursuant to  Article  7 of Regulation (EC) No  1107/2009.  
(19) The measures provided for in this Regulation are in accordance with the opinion of the  
Standing Committee on Plant s, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of the approval of the active substance  
The approval of the active substance bromoxynil  is not renewed.   
Article 2 
Amendment  to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 85 on 
bromoxynil , is deleted.  
Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
bromoxynil as an active substance by  … [Office of Publications please insert date 6 months  
from the date of entry into force ]. EN 4  EN 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] . 
Article 5  
Entry into force  
This Regulation shall enter into f orce on the third  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