EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12602/2020 Rev 1  
[…](2021) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance phosmet, 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 An nex 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 phosmet, 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 EUROPE AN 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 m arket 
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 2007/25/ EC2 included phosmet 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 subs tance phosmet , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011 , expires on 31 July 202 2. 
(4) An application for the renewal of the approval of the active substance phosmet  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 submitted 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 OJ L 106, 24.4.2007, p. 34  and OJ L 56M , 29.2.2008, p.  326. 
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 r egards the list of approved active 
substances (OJ L 153, 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). EN 2  EN (6) The rapporteur Member State prepared a  draft 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 29 September  2020. 
(7) The Authority communicated the draft 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 sum mary dossier available 
to the public  and launched a public consultation on it. On 20 August  2020,  the 
Authority communicated to the Commission its conclusion6 on whether phosmet  can 
be expected to meet the approval criteria provided for in Article 4 of Reg ulation (EC) 
No 1107/2009.  
(8) The Authority ident ified an unacceptable risk to  operators, workers, bystanders and 
residents, even with the use of personal protective equipment or application of 
available mitigation measures . It also identified  a high  acute a nd chronic  risk to 
consumers  and aquatic organisms  and a high risk to birds, mammals  and non-target 
arthropods  (including bees) . 
(9) Furthermore, the Authority could not carry out a complete consumer risk assessment 
because neither all commodities nor all potentially relevant metabolites could be 
assessed  based on the information provided by the applicant . Lastly, the Authority 
concluded that the assessment of developmental neurotoxicity could not be finalised 
since no appropriate study was submitted by the  applicant . 
(10) The Commission presented a renewal report on 26  January  2021 and a draft 
Regulation regarding phosmet to the Standing Committee on Plants, Animals, Food 
and Feed on 24  March  2021.  
(11) The Commission invited the applicant to submit its comments on t he conclusion 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.  
(12) However, despite the arguments put forward by the applicant, the concerns regarding 
the active substance  could not be eliminated.  
(13) 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 phosmet  in accordance with 
Article  20(1)(b) of that Regulation . 
(14) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly.  
(15) Member States should be given  sufficient  time to withdraw authorisations for plant 
protection products containing phosmet . 
(16) For plant protection products containing phosmet , where Member States grant any 
grace period in accordance with Article  46 of Regulation (EC) No  1107/2009, t hat 
period should  not exceed 6 months  from the date of entry i nto force of this Regulation .  
                                                 
6 Peer review of the pesticide risk assessment of the active substance phosmet  (EFSA Journal 
2021;19(3):6237 ). EN 3  EN (17) Commission Implementing Regulation (EU) XXX /XXX7 extended the approval 
period  of phosmet  to 31 July 202 2 in order to allow the renewal process to be 
completed before the expiry of the approval period . However, g iven that a decision on 
the non -renewal of the approval is taken ahead of the expiry of that  extended approval 
period , this Regulation should apply as soon as possible.  
(18) This Regulation does not prevent  the submission of a further application for the 
approv al of phosmet  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 phosmet 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 153, on phosme t, 
is deleted.  
Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant protection products containing  
phosmet  as an active substance by  … [Office of Publications please insert date 3 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 6 months from  the 
date of entry into force] . 
Article 5  
Entry into force   
This Regulation shall enter into force on the seventh  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.  
                                                 
7 {To add reference once available] OJ L   EN 4  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN