EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/641/2023  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the non -renewal of the approval of the active substance S -metolachlor, 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 S -metolachlor, 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 relev ance)  
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 
Article  20(1) and Article 78(2) thereof,  
Whereas:  
(1) Commission Directive 2005/3/EC of 19 January  20052 included S -metolachlor 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 S -metolachlor, as set out in Part A of the Annex 
to Implementing Regulation (EU) No 540/2011 , expires on 15 November  2024 . 
(4) Applications for the renewal of the approval of S -metolachlor were submitted in 
accor dance with Article 1 of Commission Implementing Regulation (EU) 
No 844/20125 within the time period provided for in that Article.  
(5) The applicants submitted the supplementary dossiers required in accordance with 
Article  6 of Implementing Regulation (EU) No  844/2012. The applications were found 
to be complete by the rapporteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p.  1. 
2 OJ L 20, 22.1.2005, p. 19.  
3 Council Directive 91/414/EEC of 1 5 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 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 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 6 September  2018 . 
(7) The Authority made the supplementary summary dossier available to the public. The 
Authority also circulated the renewal assessment report to the applicants 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 3 February 2023 , the Authority communicated to the Commission its conclusion6 
on whether S -metolachlor can be expected to meet the approval criteria p rovided for in 
Article  4 of Regulation (EC) No  1107/2009.  
(9) The Authority identified certain specific concerns. In particular, it concluded the 
potential for S -metolachlor and relevant herbicidally active metabolite s to be present 
in groundwater above the p arametric drinking water limit of 0.1  μg/L based on 
monitoring data  and that,  in addition , metabolites are  predicted to be above 0.1  µg/L in 
all scenarios for all representative uses based on groundwater modelling . High 
potential for groundwater exposure a bove the parametric drinking water limit of 
0.1 μg/L was found for  metabolites which are toxicologically relevant due to concerns 
or data gaps concerning genotoxicity and/or carcinogenicity. High risk to earthworm -
eating mammals from secondary poisoning  was also concluded.  
(10) According to the provisions of Article 14 of Implementing Regulation (EU) 
No 844/2012 , the Commission referred a draft renewal report to the Standing 
Committee on Plants, Animals, Food and Feed , for examination in May  2023. The 
draft renewal report was finalised by the Standing Committee on 12 July 2023 .  
(11) The Commission invited the applicants to submit their comments on the conclusion of 
the Authority and, in accordance with the third paragraph of Article  14(1) of 
Imple menting Regulation (EU) No  844/2012, on the draft renewal report. The 
applicants submitted their comments which have been carefully examined.  
(12) However, despite the arguments put forward by the applicants 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 the refore appropriate not 
to renew the approval of the active substance S -metolachlor.  
(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 
protect ion products containing S -metolachlor.  
(16) For plant protection products containing S -metolachlor, where Member States grant 
any grace period in accordance with Article 46 of Regulation (EC) No  1107/2009, that 
period should at the latest, expire on [ Office of Publications please insert date 
6 months from the date of entry into force ]. 
                                                 
6 Peer review of the pesticide risk assessment of the active substance S‐metolachlor excluding the 
assessment of the endocrine disrupting properties .EFSA Journal 2023;21(2):7852         
https://doi.org/10.2903/j.efsa.2023.7852 . 
 
  
EN 3  EN (17) Commission Implementing Regulation (EU) XXX/XXX of XX.XXX.XXX7 extended 
until 15 November  2024 the period of approval of S -metolachlor i n order to allow the 
renewal process to be completed before the expiry of the approval period of that 
substance. Given that a decision on the non -renewal of the approval has been taken 
ahead of that extended expiry date, this Regulation should apply as soon as possible.  
(18) This Regulation does not pre vent the submission of a further application for the 
approval of S -metolachlor 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 Plants, Anima ls, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Non-renewal of approval of active substance  
The approval of the active substance S -metolachlor 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 on S -metolachlor, is 
deleted.  
Article 3  
Transitional measures  
Member States shall withdraw authorisations for plant p rotection products containing 
S-metolachlor 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 twentieth day following that of its publication in the 
Official Journal of the European Union . 
                                                 
7 Commission Implementing Regulation (EU) …/… amending Implementing Regulation (EU) 
No 540/2011 as regards the extension of the approval periods of the active substances aclonifen, 
ametoctradin, beflubutamid, benthiavalicarb, boscalid, captan, clethodim, cyc loxydim, cyflumetofen, 
dazomet, diclofop, dimethomorph, ethephon, fenazaquin, fluopicolide, fluoxastrobin, flurochloridone, 
folpet, formetanate, Helicoverpa armigera nucleopolyhedrovirus, hymexazol, indolylbutyric acid, 
mandipropamid, metalaxyl, metaldehyd e, metam, metazachlor, metribuzin, milbemectin, paclobutrazol, 
penoxsulam, phenmedipham, pirimiphos -methyl, propamocarb, proquinazid, p rothioconazole, 
S-Metolachlor, Spodoptera littoralis nucleopolyhedrovirus, Trichoderma asperellum strain T34 and 
Trichode rma atroviride strain I -1237  (OJ L XX, XX.XX.XXXX , p.X).  
EN 4  EN This Regulation shall be binding in its entiret y and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN