G/TBT/N/EU/982  
24 May 2023  
(23-3533) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
European Commission  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
European Comm ission,  
EU-TBT Enquiry Point,  
Fax: +(32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CC CN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  S-
metolachlor (pesticide active substance)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementin g Regulation 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; (5 page(s), in English)  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance S -metolachlor is not renewed  in accordance with 
Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant 
protection products containing S -metolachlor as an active substance. The non -renewal of 
approval is based on the first evaluation of the substance fo r use as a pesticide active 
substance in the EU under Regulation (EC) No 1107/2009. The substance was formerly 
assessed and approved under Directive 91/414/ EEC.  
This decision only concerns the placing on the market of this substance and plant 
protection products containing it. Following non -approval and the expiry of all grace 
periods for stocks of products containing this substance, separate action will likely be 
taken on MRLs and a separate notification will be made in accordance with SPS 
procedures.  G/TBT/N/EU/982  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:   
In order for an active substance to be approved in accordance with Regulation (EC) No 
1107/2009 (concerning the placing of plant protection products on the mar ket), it must 
be demonstrated that the substance is not harmful to human health, animal health or the 
environment. Criteria are listed in Article 4 of the Regulation (and also detailed in Annex 
II thereto) which must be met to enable approval.  
During the e valuation and peer -review of S -metolachlor, a number of concerns and areas 
that could not be finalised were identified. These are detailed in the statement of the 
European Food Safety Authority (EFSA).  
The decision is based on a risk assessment carried out  by a rapporteur EU Member State 
and peer reviewed by the European Food Safety Authority together with all EU Member 
States, taking into account other factors legitimate to the matter.  
In the case of S -metolachlor, the outcome of the risk assessment, as do cumented in the 
EFSA Conclusion, is not favourable and identifies critical areas of concern.  
These critical areas of concern have been identified: 1) the representative uses are shown 
to contaminate groundwater (by both the active substance and the groundw ater relevant 
metabolites) and 2) all the representative uses are shown to pose risk for mammals, since 
high risk to earthworm -eating mammals via secondary poisoning was concluded.  
Moreover, part of the risk assessment could not be finalised by EFSA, thus precluding the 
renewal, such as an issue not finalised for the risk assessment of two human metabolites, 
the consumer dietary risk assessment (and the consequent livestock exposure 
assessment), and the consumer risk assessment regarding the treatment of su rface 
water. For the environmental compartment, the risk assessment for aquatic and the one 
for non -target terrestrial plants could not be finalised.  
Therefore, the outcome of the risk assessment is not favourable to the renewal given that 
it can be concluded that several application scenarios are not acceptable. These concerns 
mean that S -metolachlor does not meet the approval criteria as outlined in Regulation 
(EC) No 1107/2009.  
Existing authorisations will need to be withdrawn; EU Member States mus t withdraw 
existing plant protection products containing S -metolachlor at the latest by 3 months from 
the date of entry into force. A period of grace in line with Article 46 of Regulation 
1107/2009 is allowed for and shall expire at the latest 6 months fro m the entry into force 
(allowing for a final season of use).  
Protection of human health or safety; Protection of animal or plant life or health; 
Protection of the environment  
8. Relevant documents:   
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/EEC  
https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX:32009R1107  
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 approv ed active substances ( OJ L 153, 11.6.2011, p. 1 –186) 
https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX:32011R0540  
Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing 
Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council concerning the placing of plant protection products on the market and establishing 
a list of candidates for substitution ( OJ L 67, 12.3.2015, p. 18 –22) 
https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX:32015R0408  G/TBT/N/EU/982  
 
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  EFSA (European Food Safety Authority), 2022. Statement concerning the assessment of 
environmental fate and behaviour and ecotoxicology in the context of the pesticides peer 
review of the active substance S -metolachlor. EFSA Journal 2022; 20(11): e07634  
https://doi.org/10.2903/j.e fsa.2022.7634  
9. Proposed date of adoption:  3rd quarter 2023  
Proposed date of entry into force:  20 days following publication in the Official Journal 
of the EU  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
European Commission,  
EU-TBT Enquiry Point,  
Fax: + (32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
The text is available on the EU -TBT Website : http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_09781_00_e.pdf