   
  
G/SPS/N/EU/639  
31 May 2023  
(23-3695) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  S-metolachlor (pesticide active substance)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Commission Implementing 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 (Text with EEA relevance) . 
Language(s):  English . Number of pages:  5 
https://members.wto.org/crnattachments/2023/SPS/EEC/23_09918_00_e.pdf  
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 cont aining S -metolachlor as an active substance. The non -renewal of 
approval is based on the first evaluation of the substance for use as a pesticide active 
substance in the E uropean Union under Regulation (EC) No 1107/2009. The substance was 
formerly assessed  and approved under Directive 91/414/EEC.  
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 market), 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 evaluation 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 t he 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 documented 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 groundwater relevant G/SPS/N/EU/639  
 
- 2 - 
 
  metabolites) ; and 2) all the representati ve 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 surface water. 
For the environmental compartment, the ri sk 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 accepta ble. 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 must withdraw 
existing plant protection products containing S -metolachlor at the latest by three 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 six months from the 
entry into force (allowing for a final season of  use). 
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 li kely be 
taken on MRLs and a separate notification will be made in accordance with 
SPS procedures.  
This draft Commission Implementing Regulation was also notified under the 
TBT Agreement in notice G/TBT/N/EU/982.  
7. Objective and rationale: [X]  food safety, [X]  animal health, [X]  plant protection, 
[X] protect humans from animal/plant pest or disease, [X]  protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:   
− 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 Re gulation (EC) No 1107/2009 of the European Parliament and of the 
Council as regards the list of approved active substances (OJ L 153, 11 June 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 G/SPS/N/EU/639  
 
- 3 - 
 
  the market and establishing a list of candidates for substitution (OJ L 67, 12 March 
2015, p. 18–22) 
https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX:32015R0408  
− EFSA (European Food Safety Authority), 2022. Statement concerning the assessment 
of environmental fate a nd 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.efsa.2022.7634  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : 3rd quarter 2023.  
Proposed date of publication (dd/mm/yy) : 3rd quarter 2023.  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 20 days following publication in the Official Journal of the European Union.  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable. Comments are only welcomed  on 
TBT related issues and to be addressed to the TBT Enquiry Point on notice 
G/TBT/N/EU/982.  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (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  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (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  
 