S-Metolachlor Officially Banned in the European Union!

S-Metolachlor Officially Banned in the European Union!

On January 3, 2024, the European Commission (EC) issued an official decision stating that, pursuant to the EU Plant Protection Products (PPP) Regulation (REGULATION (EC) No 1107/2009), it will no longer approve the registration of plant protection products containing the active substance S-metolachlor within the European Union.

A draft of this decision was submitted by the EU to the World Trade Organization (WTO) in May 2023, and ChemLinked has already reported on it in a timely manner at that time. The official decision remains largely consistent with the previous draft.

S-metolachlor is a chloroacetamide herbicide developed by Novartis (now Syngenta). Its mechanism of action involves inhibiting cell growth by blocking the synthesis of very-long-chain fatty acids. With a broad spectrum of applicable crops, S-metolachlor serves as a key herbicide in major global food crops including maize and soybean fields.

As of early January 2024, S-metolachlor has obtained 24 technical product registrations and 62 formulation registrations in China. The formulated products are primarily used for controlling annual weeds. Currently, S-metolachlor holds registrations in the European Union, the United States, Canada, Australia and other countries and regions.

S-metolachlor first received approval in the EU under the former Plant Protection Products Directive (Directive 91/414/EEC) in 2005. It was subsequently included in the list of approved active substances for EU plant protection products (COMMISSION IMPLEMENTING REGULATION (EU) No 540/2011), with the approval period initially set to expire on July 31, 2014. Due to delays in the re-evaluation process, the approval period of S-metolachlor has been extended repeatedly, with the most recent extension scheduled to end on November 15, 2024.

As early as February 2023, the European Food Safety Authority (EFSA) notified the European Commission of its latest review findings on S-metolachlor, highlighting the following key risk points:

1. Monitoring data shows that the concentrations of S-metolachlor and its relevant active metabolites in groundwater exceed the limit of 0.1 μg/L. These metabolites include those that are highly suspected to have genotoxicity and carcinogenicity.

2. There is a high risk of secondary poisoning for mammals that prey on earthworms.

The European Commission invited applicants to submit comments on the review findings, but these submissions failed to address the EU's concerns regarding the risks posed by S-metolachlor. During this process, the French Agency for Food, Environmental and Occupational Health & Safety (Anses) took action in February this year, becoming the first to prohibit the primary uses of this herbicide in France. The official decision issued by the European Commission now represents the EU-level final determination that S-metolachlor fails to meet the approval criteria specified in the EU Plant Protection Products (PPP) Regulation, leading to the decision to reject the approval of this active substance.

Transition Period

In accordance with Article 46 of EU Regulation 1107/2009, following the issuance of the decision, EU Member States shall be granted sufficient time to revoke authorizations for relevant plant protection products, and an appropriate sales transition period shall be allowed for these products. Therefore, the decision stipulates that EU Member States must revoke all authorizations for plant protection products containing S-metolachlor by April 23, 2024, and the sales transition period set by each Member State shall not extend beyond July 23, 2024.