New TBT Notification: EU Considers Non-Renewal of S-metolachlor Approval
According to the TBT Notification on May 24th, 2023, the 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. Final date for comments: July 23rd, 2023.
Material Background
S-metolachlor is a chloroacetamide herbicide developed by Novartis (now Syngenta). Selective herbicide, absorbed predominantly by the hypocotyls and shoots. Inhibits germination. S-metolachlor is widely used in corn, soybean, sunflowers and beet. At present, S-metolachlor has been registered in the European Union, the United States, Canada, Australia, China and other countries and regions.
EU Review Situation
(1) Commission Directive 2005/3/EC of January 19, 2005 included S-metolachlor as an active substance in Annex I to Council Directive 91/414/EEC.
(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 540/2011.
(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 November 15, 2024.
(4) On February 3, 2023, the Authority communicated to the Commission its conclusion on whether S-metolachlor can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. These critical areas of concern have been identified:
In particular, it concluded the potential for S-metolachlor and relevant herbicidally active metabolites to be present in groundwater above the parametric 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 above 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.
(5) The applicants submitted their comments which have been carefully examined. However, despite the arguments put forward by the applicants the concerns regarding the active substance could not be eliminated.
(6) 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 risk assessment for aquatic and the one for non-target terrestrial plants could not be finalised.
(7) 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. It is therefore appropriate not to renew the approval of the active substance S-metolachlor.
The French National Agency for Food, Environmental and Occupational Health Safety (ANSES) responded in February this year, which proposes to ban the main uses of S-metolachlor herbicide.
The above information is excerpted from the Official Journal of the European Commission.
Since 2003, King Quenson has been thriving to introduce the latest technologies to agricultural industries and farmers to achieve mutual development and prosperity. With years of dedication and rich experience, King Quenson devotes more than 20 years to crop protection and offers solutions.
If you have a need, you can contact us at any time:
Email: info@kingquenson.com
Tel: 86-755-86612760, 86-755-86612793
