On May 24, 2023, the European Commission submitted to the WTO a communication (draft) on the withdrawal of the approval of the active substance spermatalachlor (S-metolachlor), with a deadline for feedback until July 23.

In this notification, the EU has recommended that the herbicide spermetolachlor (S-metolachlor) No longer be approved for the EU Register of Plant Protection Products on the basis of the Plant Protection Products PPP REGULATION (EC) No 1107/2009.  

Material background

Almeachlor is a chloroacetamide herbicide developed by Novartis (now Syngenta) that works by inhibiting cell growth by blocking the synthesis of ultra-long chain fatty acids. Metolachlor has a wide crop spectrum and is the main herbicide for corn and soybean fields, which are important food crops in the world.

As of May 2023, there are a total of 24 original drug registrations and 60 preparation registrations in China, and preparation products are mainly used to control annual weeds. At present, spermatalachlor has been registered in the European Union, the United States, Canada, Australia and other countries and regions.

EU review

In 2005, spermatalachlor was first approved by the European Union under the old Regulation on Plant Protection Products (Directive 91/414/EEC). It was later included in the List of approved active Substances for plant protection Products (COMMISSION IMPLEMENTING REGULATION (EU) No 540/2011), with the approval valid until 31 July 2014.

Due to the delay in the completion of the re-evaluation, the approval period of spermatalachlor was repeatedly postponed, the latest extension to November 15, 2024.

In February this year, the European Food Safety Authority informed the European Commission of the results of the latest review on spermatalachlor, mainly including the following risk points:

According to the monitoring data, the content of metolachlor and its related active metabolites in groundwater exceeded 0.1. g/L limit values, which include metabolites that are highly suspected of genotoxicity and carcinogenicity.

There is a high risk of secondary toxicity for earthworm feeding mammals.

The European Commission invited applicants to submit comments on the findings of the review, but it did not eliminate the EU's concern about the risk points of spermatalachlor.

In this process, the French Food, Environment and Occupational Health Safety Agency (Anses) responded in February this year, the first to ban the main use of the herbicide in France, and the latest WTO notification means that the EU level has finally decided that mealachalamine does not meet the approval criteria of the EU PPP Regulation for plant protection products. It was decided not to approve the active substance.

Effective time and buffer period

At present, the EU has not issued a formal decision to ban spermatalachlor.

According to the content of the EU's notification to the WTO, the recently issued validity extension decision (extended to November 15, 2024) will be void, and the EU will issue a ban decision as soon as possible before then.

The ban resolution will take effect 20 days after it is issued. Member States are required to withdraw the authorisation of the relevant plant protection products within three months after the issuance of the decision, and the buffer period for granting the relevant plant protection products by Member States shall not exceed six months.