EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/1836  CIS  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance oxamyl, in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council, and amending 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 oxamyl, in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council, and amending Commission Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the Europ ean 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 2006/16 /EC2 included oxamyl  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 oxamyl , as set out in Part A of the Annex to 
Implementing Re gulation (EU) No  540/2011 , expires on 31 October  2023. 
(4) An application for the renewal of the approval of the active substance oxamyl  was 
submitted to Italy, the rapporteur Member State, and France, the co -rapporteur 
Member State, in accordance with Article 1 of Commission Implementing Regulation 
(EU) No 844/20125 within the time period provided for in that Article.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2006/16/EC of 7 February 2006 amending Council Directive 91/414/EEC to 
include oxamyl as active substance (OJ L 36, 8.2.2006, p. 39). 
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 15 3, 11.6.2011, p.  1). 
5 Commission Implementing Regulation (EU) No 844/2012 of 18 September 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 products on the market (OJ L 252, 19.9.2012, p. 26). This Regulation was 
replaced by Regulation (EU) 2020/1740, however, it continues to apply to the procedure for the re newal 
of the approval of active substances: (1) whose approval period ends before 27 March 2024; (2) for 
which a Regulation, adopted in accordance with Article 17 of Regulation (EC) No 1107/2009 on or 
after 27 March 2021, extends the approval period to 27 March 2024 or a later date.    
EN 2  EN (5) The applicant submitted the supplementary dossiers to the rapporteur Member State, 
the co -rapporteur Member State, the  Commission and the European Food Safety 
Authority (‘the Authority’)  in accordance with Article  6 of Implementing Regulation 
(EU) No 844/2012. The application was found to be complete by the rapporteur 
Member State.  
(6) The rapporteur Member State prepared a  draft renewal assessment report in 
consultation with the co -rapporteur Member State and submitted it to the Authority 
and the Commission on 15 October  2019 . 
(7) The Authority made the supplementary summary dossier available to the public. The 
Authority also cir culated the draft renewal assessment report to the applicant and to 
the Member States for comments and launched a public consultation on it. The 
Authority forwarded the comments received to the Commission.  
(8) On 30 March 2022 , the Authority communicated  to the Commission its conclusion6 on 
whether oxamyl  can be expected to meet the approval criteria provided for in Article  4 
of Regulation (EC) No  1107/2009.  
(9) In its conclusion, t he Authority ident ified a number of concerns . In particular , it 
concluded that  there is a high risk for all the representative uses assessed to exceed the 
acceptable operator exposure level (‘AOEL’) for operators even with the use of persona l 
protective equipment (‘PPE’) .  
(10) Furthermore , the preliminary acute  consumer dietary risk assessment indicated a large 
exceedance of the acute reference dose  (‘ARfD ‘) for all the representative use s on all 
edible crops . In addition , the consumer risk assessment through drinking water indicated 
that the theoretical maximum  daily intake  (‘TMDI’) from  the groundwater metabolite 
IN-D2708 exceeded the acceptable daily intake (‘ADI’)  for adults, child ren and infants in 
all representative uses and  that the TMDI from the groundwater metabolite IN -A2213 
exceeded the ADI  for infants  in all representative uses.  
(11) The Commission presented a renewal report concerning the approval of oxamyl as well 
as a draft of this Regulation to the Standing Committee on Plant s, Animals, Food and 
Feed  on 13 October  2022 and 8  December  2022  respectively . 
(12) The Commission invited the applicant to submit its comments on the conclusion of the 
Authority. Furthermore, in accordance with Article  14(1) , third subparagraph, of 
Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to 
submit c omments on the renewal report.  
(13) 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 therefore appropriate not 
to renew the approval of the active substance oxamyl . 
(15) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
                                                 
6 EFSA Journal 2022;20(5):7296 . 
  
EN 3  EN (16) Member States should be given  sufficient  time to withdraw authorisations for plant 
protection products containing oxamyl.  
(17) For plant protection products containing oxamyl , where Member States grant any 
grace  period in accordance with Article  46 of Regulation (EC) No  1107/2009, t hat 
period should  at the latest, expire on … [ Office of Publications, please insert date 1 2 
months from the date of entry into force of this Regulation ].  
(18) Commission Implementing Regul ation (EU) 2022/XXXX7 extend s the approval 
period  of oxamyl  to 31 October  2023 in order to allow the renewal process to be 
completed before the expiry of the approval period . However, g iven that this process 
has been completed and  a decision on the non -renewal of the approval taken ahead of 
that extended approval period, the non -renewal provided for in this Regulation shou ld 
take effect earlier than that date . 
(19) This Regulation does not prevent  the submission of a further application for the 
approval of oxamyl  pursuant to  Article 7 of Regulation (EC) No  1107/2009.  
(20) 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 oxamyl  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 116 on oxamyl  is 
deleted.  
Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing oxamyl  
as an active substance by  … [Office of Publications please insert date 6 months from the date 
of entry into force  of this Regulation ] at the latest . 
                                                 
7 XXX (OJ L XXX, XX.X.20XX, p. XX).  
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  of this Regulation ] 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 applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN