EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12984/2019 Rev. 0  
[…](2021) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance famoxadone, 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 Commiss ion Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)   EN 2  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of approval of the active substance famoxadone, 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 Commission Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)  
THE EUROPEAN COMMI SSION,  
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 
Article  20(1) and Article  78(2) thereof,  
Whereas:  
(1) Commission Directive 2002 /64/EC2 included famoxadone  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 substance famoxadone , as set out in Part  A of the Annex to 
Implementing Regulation (EU) No  540/2011 , expires on 30 June 2021. 
(4) An application for the renewal of the approval  of famoxadone  was submitted in 
accordance with Article  4 of Commission Implementing Regulation (EU) 
No 1141 /20105 within the time period provided for in that Article.  
(5) The applicant submitted the supplementary dossiers required in accordance with 
Article  9 of Implementing Regulation (EU) No  1141 /2010. The application was found 
to be comple te by the rapporteur Member State.   
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2002/64/EC of 15 July 2002 amending Council Directive 91/414/EEC to include 
cinidon -ethyl, cyhalofop butyl, famoxadone, florasulam, metalaxyl -M and picolinafen as active 
substances  (OJ L 189, 18.7.2002, p.  31). 
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 amending 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 Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the 
renewal of the inclusion of a second group of active substances in Annex I to Council Directive 
91/414/EEC and establishing the list of those substances ( OJ L  322, 8.12.2010, p.  10). EN 3  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 Food Safety 
Authority (‘the Authority’) and the Commission on 15 July 2014 . 
(7) The Authority communicated the renewal assessment report to the applicant and to the 
Member States for comments and forwarded the comments received to the 
Commission. The Authority also made the supplementary summary dossier available 
to the public.  
(8) On 3 July 2015  the Authority communicated to the Commission its conclusion6 on 
whether famoxadone  can be expected to meet the approval criteria provided for in 
Article  4 of Regulation (EC) No  1107/2009. The Authority concluded that there is a 
high potential for all the representative uses assessed to exceed the acceptable operator 
exposure level (‘ AOEL ’) for worker s during crop hand -harvesting even with  the use of  
personal protective equipment  (‘PPE’). The Authority  further concluded that  there is a 
high long -term risk for mammals  and high risk for aquatic organisms  from  the use of 
famoxadone.  In a ddition , the Authority stated  that the available information is 
insufficient to  conclude on the the long -term risk assessments for birds . 
(9) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority  and, in accordance with Article  17(1) of Implementing Regulation (EC) 
No 1141 /2010 , on the draft review report. The applicant submitt ed its comments, 
which have been carefully examined.  
(10) However, despite the arguments put forward by the applicant, the concerns related to 
the substance  could not be eliminated.  
(11) 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 therefore appropriate not 
to renew the approval of the active substance famoxadone  in acc ordance with 
Article  20(1)(b) of that Regulation.  
(12) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly . 
(13) Member States should be allowed sufficient time to withdraw authorisations for plant 
protection products containing famoxado ne.  
(14) For plant protection products containing famoxadone , where Member States grant any 
grace period  in accordance  with Article  46 of Regulation (EC) No  1107/2009, that 
period should  be as short as possible and  not exceed 12 months from the date of entry 
into force of this Regulation . 
(15) This Regulation does not prevent  the submission of a further application for the 
approval of famoxadone  pursuant to Article  7 of Regulation (EC) No  1107/2009.  
(16) The measures provided for in this R egulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
                                                 
6  Conclusion on the peer review of the pesticide risk assessment of the active substance famoxadone. 
EFSA Journal 2015;13(7):4194, 116 pp. doi:10.2903/j.efsa.20 15.4194 .  EN 4  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of approval of active substance  
The approval of the active substance famoxadone  is not renewed.   
Article 2  
Amendment to Implementing Regulation (EU) No 540/2011  
In Part A of the Annex to Implementing Re gulation (EU) No 540/2011, row 35, on 
famoxadone , is deleted.  
Article 3 
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing 
famoxadone  as active substance by [Office of Publications : please insert date 6 months  from  
the date of entry into force ]. 
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 force 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 t he Commission  
 The President  
 Ursula VON DER LEYEN  